FDA Adverse Event
Summary report: N
XEROFRM GZE 1X8 PTCH FOIL PK STRL
MDR report key: 479871
·
Received August 22, 2003
Report
- Report Number
- 1314412-2003-00003
- Date Received
- August 22, 2003
- Date of Event
- June 27, 2003
- Report Date
- August 22, 2003
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- MGB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL IN 7/2003 THAT IT WAS NECESSARY TO PUT A PT UNDER ANESTHESIA TO REMOVE XEROFORM GAUZE THAT WAS ADHERING TO A FRESH CIRCUMCISION SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XEROFRM GZE 1X8 PTCH FOIL PK STRL | WOUND DRESSING | MGB | TYCO HEALTHCARE/KENDALL | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Required Intervention |