DISPPATCBL 2.0 6FT W 8PK
Received Jul 16, 2026 · Event occurred Jun 26, 2026
Report 0002242056-2026-00009 · MDR key 25840271
Device
Generic name
Cable, Electrode
Manufacturer
A&e Medical CorporationModel number
NICatalog number
019-530
Lot number
30082
Product problems
- Delivered as Unsterile Product
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT NURSING STAFF IDENTIFIED HAIR WITHIN THE SEAL OF STERILE PACKAGING EXTENDING INTO THE STERILE PRODUCT. THE ISSUE WAS IDENTIFIED DURING INSPECTION OF THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.