InjuryFOX
STATLOCK IV ULTRA NEO CATHETER RETAINER, ULTRA NEONATE PADS 25 BOX
Received Jun 4, 2021 · Event occurred Feb 22, 2021
Report 3006260740-2021-02181 · MDR key 11939146
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
IV0501
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Ulcer
- Ulcer
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem
IT WAS REPORTED "WOUND TEAM REPORTED TO RISK MANAGEMENT THAT THE DEFECTED PRODUCT IS CREATING STAGE 3 AND 4 PRESSURE INJURIES." IT WAS STATED THIS OCCURRED WITH 9 DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.