FDA Adverse Event
Other
Summary report: N
NEOSPORIN SCAR SHEETS
MDR report key: 642264
·
Received October 19, 2005
Report
- Report Number
- 2246407-2005-00012
- Event Type
- Other
- Date Received
- October 19, 2005
- Date of Event
- October 1, 2004
- Report Date
- October 17, 2005
- Manufacturer
- PFIZER INC.
- Product Code
- MDA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEOSPORIN SCAR SHEETS | ELASTOMER, SILICONE, FOR SCAR MANAGEMENT | MDA | PFIZER INC. | UNK | 20056-5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |