PROCARE
Received Nov 7, 2024 · Event occurred Oct 14, 2024
Report 9616086-2024-00099 · MDR key 20627238
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Laceration(s)
- Laceration(s)
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT METAL BARS BROKE THROUGH THE STITCHING AND INTO PATIENTS SKIN, CAUSING THE SKIN TO BREAK AND BLEED OUT AND ONTO THE ORIGINAL PRODUCT, NEW PRODUCT WAS PROVIDED BECAUSE OF THE INITIAL INJURY. CLINIC DISCARDED THIS PRODUCT PRIOR TO THE REP VISIT WITH THE PATIENT. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE ESTABLISHED. IF MORE INFORMATION BECOMES AVAILABLE ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT.
Description of Event or Problem
IT WAS REPORTED THAT METAL BARS BROKE THROUGH THE STITCHING AND INTO PATIENTS SKIN, CAUSING THE SKIN TO BREAK AND BLEED OUT AND ONTO THE ORIGINAL PRODUCT, NEW PRODUCT WAS PROVIDED BECAUSE OF THE INITIAL INJURY. CLINIC DISCARDED THIS PRODUCT PRIOR TO THE REP VISIT WITH THE PATIENT.