PROTECTOR,ULNAR NERVE,CONV FOAM,36PR/CS
Received Mar 19, 2021 · Event occurred Feb 15, 2021
Report 1417592-2021-00039 · MDR key 11528812
Device
Generic name
Protector,ulnar Nerve,conv Foam,36pr/cs
Manufacturer
Medline Industries Inc.Catalog number
NON081340
Lot number
201106.3.32024
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pressure Sore/Ulcer
- Pressure Sore/Ulcer
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT, FOLLOWING AN UNSPECIFIED PROCEDURE, A PATIENT WAS NOTED TO HAVE EXPERIENCED A "PRESSURE SORE" TO AN UNSPECIFIED PART OF THE BODY. NO DESCRIPTION OF THE PRESSURE SORE, MEDICAL INTERVENTION, OR FOLLOW-UP CARE WAS REPORTED TO THE MANUFACTURER. AT THIS TIME, NO SAMPLE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A ROOT CAUSE WAS UNABLE TO BE DETERMINED. DUE TO THE REPORTED INCIDENT, AND IN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A "PRESSURE SORE."