FDA Adverse Event
Other
Summary report: N
BARRIER ULTRA PROTECTION SURGICAL GOWN, EXTRA, EXTRA LARGE
MDR report key: 389443
·
Received April 23, 2002
Report
- Report Number
- 2523357-2002-00001
- Event Type
- Other
- Date Received
- April 23, 2002
- Date of Event
- April 2, 2002
- Report Date
- April 23, 2002
- Manufacturer
- MOLNLYCKE HEALTH CARE, INC.
- Product Code
- FYE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
SURGEON WAS PERFORMING A "SOMEWHAT BLOODY" PROCEDURE AND EXPERIENCED STRIKETHROUGH, WHILE WEARING THE BARRIER ULTRA PROTECTION SURGICAL GOWN, PRODUCT CODE 0583. BLOOD SOAKED THROUGH TO THE SURGEON'S SCRUBS, INCLUDING ARMS AND CHEST. NO KNOWN EXPOSURE TO BLOODBORNE PATHOGENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARRIER ULTRA PROTECTION SURGICAL GOWN, EXTRA, EXTRA LARGE | GOWN, SURGICAL | FYE | MOLNLYCKE HEALTH CARE, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |