Received Jun 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | 1 | W1B511M | OT |
administration of Ipol after Temperature excursion not viable for use which reached 47.03F for 41 mins due to a failure of battery backup with no adverse event; Initial information received on 19-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old male patient (36 cm and 18.64 kg) for whom administration of IPV (VERO) [IPOL] after temperature excursion not viable for use which reached 47.03f for 41 mins due to a failure of battery backup with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a Dose 1 (0.5ml) of suspect IPV (VERO); Suspension for injection with unknown strength (lot W1B511M with expiry date 08-SEP-2025) via intramuscular route in unknown administration site for Immunization; after temperature excursion not viable for use which reached 47.03f for 41 mins due to a failure of battery backup with no adverse event (poor quality product administered) (latency: same day) Reportedly: patient was advising and scheduled to repeat. No previous excursion reported. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: 2025SA164290:IT-00537292