UNKNOW OR PRODUCT
Received Nov 9, 2016 · Event occurred Oct 19, 2016
Report 3009211636-2016-00458 · MDR key 6088859
Product problems
- Torn Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 11/9/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED. FOLLOW UP ATTEMPTS WERE MADE (B)(6) WITH NO RESPONSE. THE CUSTOMER REPORTED MULTIPLE INCIDENTS, BUT SPECIFIC DETAILS AND LOTS HAVE NOT BEEN PROVIDED. THIS COMPLAINT WILL BE FILED AS ONE REPORT AND IF ADDITIONAL INFORMATION AND IF INDIVIDUAL LOTS ARE REPORTED, ADDITIONAL REPORTS WILL BE GENERATED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS WE HAVE HAD MANY INCIDENTS WHERE THE LIGHT HANDLES HAVE SPLIT AND I HAVE ONE HERE THIS MORNING.
Additional Manufacturer Narrative
THE REPORT WAS INITIALLY FILED INCORRECTLY AGAINST COVIDIEN, MANUFACTURING (B)(4) AND SHOULD HAVE BEEN FILED UNDER PLANT: COVIDIEN, (B)(4).