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