MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-10-19 for NEOSPORIN SCAR SHEETS UNK manufactured by Pfizer Inc..
[412191]
A female consumer used two sheets of neosporin scar solution (silicone) every 3 to 4 days beginning in 2004 (exact date unspecified) for a surgical scar. Two months later she was informed that she had lung cancer. In 2005 (exact date unspecified), the consumer had an x-ray and unspecified scan that showed bone cancer. Product use was discontinued on an unspecified date. As of 2005, the events had not yet resolved. No further information was available at the time of the report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246407-2005-00012 |
| MDR Report Key | 642264 |
| Report Source | 04 |
| Date Received | 2005-10-19 |
| Date of Report | 2005-10-17 |
| Date of Event | 2004-10-01 |
| Date Mfgr Received | 2005-10-10 |
| Date Added to Maude | 2005-10-24 |
| 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 RAOD |
| 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 | 2005-10-19 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 20056-5 |
| ID Number | UNK |
| Device Expiration Date | 2006-12-31 |
| 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 | 631795 |
| Manufacturer | PFIZER INC. |
| Manufacturer Address | * MORRIS PLAINS NJ 07950 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-10-19 |