GOMCO
Received Jan 30, 2026 · Event occurred Dec 16, 2025
Report 1924066-2026-00001 · MDR key 24225331
Device
Generic name
500 Circ Clamp,newborn,
Manufacturer
Allied Medical Llc.Model number
02-01-0500Catalog number
02-01-0500
Lot number
1223
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 DEFECTIVE. PHOTOGRAPHS PROVIDED BY THE COMPLAINANT SHOWED SURFACE IRREGULARITIES AND WEAR AROUND THE PLATE OPENING FOR THE BELL THAT APPEARED INCONSISTENT WITH THE EXPECTED CONDITION OF THE DEVICE. THE CLAMP WAS IDENTIFIED AS HAVING A MANUFACTURING DATE OF DECEMBER 2023. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED TO A REVIEW OF THE IMAGES PROVIDED. BASED ON THE VISUAL EVIDENCE AVAILABLE, THE OBSERVED SURFACE CONDITION MAY BE CONSISTENT WITH SUBOPTIMAL PLATING. HOWEVER, IN THE ABSENCE OF THE PHYSICAL DEVICE, NO DEFINITIVE CONCLUSIONS REGARDING THE DEVICE CONDITION OR ROOT CAUSE COULD BE CONFIRMED.
Description of Event or Problem
AS PER CLIENT, THE CIRCUMCISION CLAMPS THEY ORDERED SEEM TO BE DEFECTIVE.