FDA Adverse Event
Malfunction
Summary report: N
MER STAND, INTERNATIONAL
MDR report key: 10950598
·
Received December 5, 2020
Report
- Report Number
- 3006260740-2020-20805
- Event Type
- Malfunction
- Date Received
- December 5, 2020
- Date of Event
- November 12, 2020
- Report Date
- November 21, 2020
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- FOX
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. A HISTORY REVIEW IS NOT POSSIBLE; AS THE MER STAND IS NOT LABELED WITH A SERIAL NUMBER.
Description of Event or Problem · 1
CUSTOMER REPORTS BROKEN HANDLE ON USG CART, MAKING TRANSPORTATION DIFFICULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1420545 | MER STAND, INTERNATIONAL | STAND, INFUSION | FOX | C.R. BARD, INC. (BASD) -3006260740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |