MalfunctionHJZ
PTOSIS SLING
Received Nov 3, 2021 · Event occurred Sep 24, 2021
Report 12744788 · MDR key 12744788
Device
Product problems
- Break
- Material Twisted/Bent
Patient
22995 DA
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A BOX OF 3 WAS PURCHASED. THE FIRST SLING WAS BENT AND UNUSABLE. THE SECOND SLING WAS OPENED AND BROKE DURING INSERTION: THIS ONE HAD PATIENT CONTACT BUT NO PATIENT HARM. THE THIRD SLING WAS ABLE TO BE PLACED. MANUFACTURER RESPONSE FOR PTOSIS SLING SET, (BRAND NOT PROVIDED) (PER SITE REPORTER). THEY WILL SEND RETURN KIT AND ISSUE CREDIT.