FDA Adverse Event
Other
Summary report: N
BARRIER EXTRA PROTECTION SURGICAL GOWN, EXTRA LARGE
MDR report key: 226782
·
Received June 9, 1999
Report
- Report Number
- 1618732-1999-00174
- Event Type
- Other
- Date Received
- June 9, 1999
- Report Date
- June 1, 1999
- Manufacturer
- JOHNSON & JOHNSON MEDICAL
- 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
ACCOUNT CONTACT REPORTS: AN ORTHOPEDIC SURGEON RECEIVED STRIKETHROUGH ON A SURGICAL GOWN. THE AREA OF STRIKETHROUGH WAS NOT KNOWN TO THE CONTACT. THE PROCEDURE WAS A TOTAL KNEE. THE PT DID NOT HAVE ANY KNOWN BLOODBORNE DISEASES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARRIER EXTRA PROTECTION SURGICAL GOWN, EXTRA LARGE | GOWN, SURGICAL | FYA | JOHNSON & JOHNSON MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |