MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-11-21 for NEOSPORIN SCAR SOLUTION * manufactured by Pfizer Inc..
[18822340]
One of two cases reported by the same reporter. A pregnant female consumer began using one neosporin scar solution sheet (silicone) every 3 to 4 days in 2006 (exact date unspecified) for scar reduction. At time of reporting, the outcome of the pregnancy and product use were unknown. Follow-up information received by pfizer on nov 08, 2006 has upgraded this case to serious. The consumer reported that during a routine pregnancy check-up in 2006 (exact date unspecified), she was informed that the fetus passed away in utero. The consumer stated "the fetus no longer had a heartbeat". The consumer further stated the doctor was unable to determine the cause of death due to the length of time that had passed since the intra-uterine death. The consumer requested no further contact.
Patient Sequence No: 1, Text Type: D, B5
[19032489]
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 | 2246407-2006-00011 |
| MDR Report Key | 785780 |
| Report Source | 04 |
| Date Received | 2006-11-21 |
| Date of Report | 2006-11-08 |
| Date of Event | 2006-01-01 |
| Date Mfgr Received | 2006-11-08 |
| Date Added to Maude | 2006-11-24 |
| 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 RD |
| 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 SOLUTION |
| Generic Name | ELASTOMER, SILICONE, FOR SCAR MANAGEMENT |
| Product Code | MDA |
| Date Received | 2006-11-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 773579 |
| Manufacturer | PFIZER INC. |
| Manufacturer Address | * MORRIS PLAINS NJ 07950 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2006-11-21 |