NS-3600-B LITE GLOVE 1000/CASE
Received Nov 23, 2016
Report 9612030-2016-00718 · MDR key 6124662
Product problems
- Split
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 11/23/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT AN ISSUE OCCURRED WITH A LITE GLOVE. THE CUSTOMER REPORTS SPLIT LIGHT HANDLE COVERS.
Additional Manufacturer Narrative
SUBMIT DATE: 12/12/2016. WAS UPDATED TO INCLUDE ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT AN ISSUE OCCURRED WITH A LITE GLOVE. THE CUSTOMER REPORTS SPLIT LIGHT HANDLE COVERS. THE AFFECTED QUANTITY WAS 25 EACH, NO PATIENTS INVOLVED. ISSUES WERE DISCOVERED DURING SET UP. IT IS UNKNOWN IF THE LITE GLOVES WERE TOO TIGHT WHEN BEING PLACED. A NEW GLOVE WAS PLACED WHEN ISSUE WAS NOTICED. LOT NUMBER IS UNKNOWN BECAUSE THE COMPONENTS ARE NOT LOT TRACKED.