FDA Adverse Event
Other
Summary report: N
BARRIER EXTRA PROTECTION SURGICAL GOWN, LG
MDR report key: 494997
·
Received November 7, 2003
Report
- Report Number
- 2523357-2003-00008
- Event Type
- Other
- Date Received
- November 7, 2003
- Date of Event
- October 6, 2003
- Report Date
- November 7, 2003
- Manufacturer
- MOLNLYCKE HEALTH CARE AB
- Product Code
- FYE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
NURSE REPORTED STRIKETHROUGH WHILE EVALUATING AN IMPERVIOUS GOWN. HOWEVER, IT WAS NOT CONFIRMED THAT FLUID ACTUALLY STRUCK THROUGH TO THE USER'S SCRUBS. NO KNOWN BLOODBORNE PATHOGENS; NO ADVERSE CLINICIAN IMPACT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARRIER EXTRA PROTECTION SURGICAL GOWN, LG | GOWN, SURGICAL | FYE | MOLNLYCKE HEALTH CARE AB | NA | Z240102F06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |