FDA Adverse Event
Malfunction
Summary report: N
AMD RITMED
MDR report key: 1189384
·
Received September 11, 2008
Report
- Report Number
- 1189384
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- September 9, 2008
- Report Date
- September 11, 2008
- Manufacturer
- AMD RITMED
- Product Code
- KKX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT, US
Narratives
Description of Event or Problem · 1
TOWEL PACK WAS FOUND TO HAVE SLASH MARKS ON THE INNER PACKAGE. THE OUTSIDE PACKAGING WAS NOT DAMAGED. THIS TYPE OF DAMAGE HAD TO HAVE HAPPENED IN PACKAGING. THE PROBLEM WAS NOTICED AS THE ROOM WAS BEING REPAIRED. THE PATIENT WAS NOT INVOLVED OR IN ROOM AT THE TIME.====================== MANUFACTURER RESPONSE FOR O.R. TOWEL, AMD RITMED======================DISTRIBUTOR SUPPLIED RETURN AUTHORIZATION NUMBER FOR RETURN PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMD RITMED | TOWEL, OPERATING ROOM | KKX | AMD RITMED | 5006-B | 5333-00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |