MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-08-29 for NEOSPORIN SCAR SHEETS UNK manufactured by Pfizer, Inc..
[495897]
A female consumer applied part of a neosporin scar sheet (silicone) once daily beginning in 2006, to a scar on her face from recent mole removal surgery. Two days later, she had hives. She continued product use and thirteen days later, the hives were all over her body. The consumer went to the er that same day, where she was treated with three unspecified injections and benadryl (unspecified). Prior to that day, product use was discontinued and the event resolved.
Patient Sequence No: 1, Text Type: D, B5
[7798829]
The product was not returned for failure analysis/laboratory testing. It cannot be ruled out that the product may have possibly caused the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246407-2006-00005 |
| MDR Report Key | 756875 |
| Report Source | 04 |
| Date Received | 2006-08-29 |
| Date of Report | 2006-08-29 |
| Date of Event | 2006-08-09 |
| Date Mfgr Received | 2006-08-22 |
| Date Added to Maude | 2006-09-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 201 TABOR ROAD |
| Manufacturer City | MORRIS PLAINS NJ 07950 |
| Manufacturer Country | US |
| Manufacturer Postal | 07950 |
| Manufacturer Phone | 9733850704 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOSPORIN SCAR SHEETS |
| Generic Name | ELASTOMER, SILICONE, FOR SCAR MANAGEMENT |
| Product Code | MDA |
| Date Received | 2006-08-29 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 22040-27 |
| ID Number | UNK |
| Device Expiration Date | 2007-10-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 744772 |
| Manufacturer | PFIZER, INC. |
| Manufacturer Address | * * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-08-29 |