InjuryGAD
BLACK & BLACK SURGICAL
Received Sep 19, 2025 · Event occurred Aug 19, 2025
Report 3006142527-2025-00001 · MDR key 23100260
Device
Generic name
Retractor
Manufacturer
Black & Black SurgicalModel number
B61029Catalog number
B61029
Lot number
UNKNOWN
Product problems
- Overheating of Device
- Overheating of Device
Patient
NA · Unknown
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
THE FACILITY WAS CONTACTED 4 TIMES TO RECEIVE THE SUSPECT DEVICES FOR EVALUATION BUT THE FACILITY NEVER SENT THE ITEMS BACK. THE EXACT ITEM NUMBER, LOT, AND FULL DETAILS OF PATIENT BURN ARE UNKNOWN. IF FURTHER INFORMATION OR DEVICE IS RECEIVED BACK, A FOLLOW UP REPORT WILL BE ISSUED.
Description of Event or Problem
WE WERE INFORMED THAT DURING A PROCEDURE, A PATIENT WAS BURNED WITH THE FIBEROPTIC RETRACTOR THAT WAS BEING USED.