FDA Adverse Event
Other
Summary report: N
BARRIER PACK
MDR report key: 177797
·
Received July 17, 1998
Report
- Report Number
- 1618732-1998-00156
- Event Type
- Other
- Date Received
- July 17, 1998
- Report Date
- June 17, 1998
- Manufacturer
- JOHNSON & JOHNSON MEDICAL, INC.
- Product Code
- FYA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTS: BLOOD SOAKED THROUGH THE FRONT OF AN IMPERVIOUS GOWN. THE EXACT GOWN WAS NOT KNOWN TO THE CUSTOMER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARRIER PACK | PACK, SURGICAL | FYA | JOHNSON & JOHNSON MEDICAL, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |