MalfunctionHFX
GOMCO
Received Jan 30, 2026 · Event occurred Jan 2, 2026
Report 1924066-2026-00002 · MDR key 24225332
Device
Generic name
500 Circ Clamp,newborn,
Manufacturer
Allied Medical Llc.Model number
02-01-0500Catalog number
02-01-0500
Lot number
0325
Product problems
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A COMPLAINT WAS RECEIVED ALLEGING THAT A CLAMP WAS FLAKING. THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE IDENTIFIED SURFACE FLAKING, WHICH MAY BE INDICATIVE OF A PLATING-RELATED ISSUE.
Description of Event or Problem
FLAKING.