MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-05-23 for NEOSPORIN SCAR SOLUTION manufactured by Pfizer Inc.
[630957]
A female consumer used 1/2 a patch of neosporin scar solution (silicone) 16 hours daily in 2007 to reduce a scar on her shoulder due to surgery two weeks prior to use of the prod. Approx one month later, she began to notice a redness around the application site area. About 3-4 days later (exact date unspecified) she consulted with her surgeon who stated that she had necrotic tissue under her skin. Several unspecified tests were performed and it was noted that there was no bacterial or viral infection. She also reported that the affected area began growing in size and was currently about 2 inches by 4 inches. She has been returning to her physician every two days to have the "liquified tissue" (fluid) removed through a syringe. At about 2 weeks later, consumer stated that she was scheduled to go to surgery that morning and was unavailable for follow-up. Prod use was discontinued one day prior to notice a redness around the site area. At the time of reporting, the outcome of the events was resolved.
Patient Sequence No: 1, Text Type: D, B5
[7965510]
Analysis/lab testing. It cannot be ruled out that the prod may have possibly caused the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246407-2007-00002 |
| MDR Report Key | 855338 |
| Report Source | 04 |
| Date Received | 2007-05-23 |
| Date of Report | 2007-05-16 |
| Date of Event | 2007-05-16 |
| Date Mfgr Received | 2007-05-16 |
| Date Added to Maude | 2007-09-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 201 TABOR ROAD |
| Manufacturer City | MORRIS PLAINS NJ 07950 |
| Manufacturer Country | US |
| Manufacturer Postal | 07950 |
| Manufacturer Phone | 9733850704 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOSPORIN SCAR SOLUTION |
| Generic Name | ELASTOMER, SILICONE, FOR SCAR MGMT |
| Product Code | MDA |
| Date Received | 2007-05-23 |
| Lot Number | 20013-A |
| Device Expiration Date | 2007-09-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 843883 |
| Manufacturer | PFIZER INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-23 |