FDA Adverse Event
Malfunction
Summary report: N
POST MORTEM KIT
MDR report key: 8703651
·
Received June 17, 2019
Report
- Report Number
- 8703651
- Event Type
- Malfunction
- Date Received
- June 17, 2019
- Date of Event
- May 16, 2019
- Report Date
- May 23, 2019
- Manufacturer
- BUSSE HOSPITAL DISPOSABLES, INC.
- Product Code
- LRO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
WE HAVE BEEN EXPERIENCING PROBLEMS WITH BODY BAGS FOR A FEW YEARS. THEY ARE RIPPING. MY UNIFORM GOT CONTAMINATED SO BAD THAT I HAD TO COMPLETELY CHANGE MY UNIFORM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 499625 | POST MORTEM KIT | GENERAL SURGERY TRAY | LRO | BUSSE HOSPITAL DISPOSABLES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |