FDA Adverse Event
Other
Summary report: N
BIOCLUSIVE TRANSPARENT DRESSING-MOISTURE VAPOR PERMEABLE
MDR report key: 335733
·
Received May 30, 2001
Report
- Report Number
- 1618732-2001-00052
- Event Type
- Other
- Date Received
- May 30, 2001
- Report Date
- May 29, 2001
- Manufacturer
- JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC.
- Product Code
- MGQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
END USER REPORTEDLY USED THE BIOCLUSIVE TRANSPARENT DRESSING IN CONJUNCTION WITH THE DURAGESIC PATCH, WHEN END USER EXPERIENCED "A TOXIC REACTION". END USER EXPERIENCED RINGING IN THE EARS, RAPID WEIGHT LOSS AND WEAKNESS". REPORTED THAT THE PRODUCT GAVE OFF AN ODOR OF STRONG PERSPIRATION. SPENT NINE HOURS IN EMERGENCY ROOM UNDERGOING VARIOUS TESTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24980 | BIOCLUSIVE TRANSPARENT DRESSING-MOISTURE VAPOR PERMEABLE | DRESSING, SURGICAL WOUND | MGQ | JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. | NA | 2000-04/1042000T22 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention | DURAGESIC PATCH. |