FDA Adverse Event
Other
Summary report: N
BIOCLUSIVE TRANSPARENT DRESSING- MOISTURE VAPOR PERMEABLE
MDR report key: 274794
·
Received April 21, 2000
Report
- Report Number
- 1618732-2000-00058
- Event Type
- Other
- Date Received
- April 21, 2000
- Report Date
- March 24, 2000
- Manufacturer
- JOHNSON & JOHNSON MEDICAL
- Product Code
- MGQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CONSUMER WAS GIVEN THE PRODUCT TO HOLD CONSUMER'S ANALGESIC PATCH IN PLACE. THE PRODUCT WAS IN PLACE FOR THREE DAYS. WHEN CONSUMER ATTEMPTED TO REMOVE THE PATCH CONSUMER'S SKIN CAME OFF WITH THE PRODUCT. CONSUMER REPORTS THAT CONSUMER ATTEMPTED TO PEEL PACK THE EDGE WHILE HOLDING DOWN CONSUMER'S SKIN DURING REMOVAL. CONSUMER HAS SEEN THE DOCTOR AND WAS PRESCRIBED A PERSCRIPTION TO TREAT THE AREA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOCLUSIVE TRANSPARENT DRESSING- MOISTURE VAPOR PERMEABLE | DRESSING, SURGICAL WOUND | MGQ | JOHNSON & JOHNSON MEDICAL | NA | 0330T32 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |