MalfunctionEIE
HYGENIC
Received Oct 23, 2018
Report 2416455-2018-00013 · MDR key 7996461
Device
Product problems
- Material Integrity Problem
- Detachment of Device or Device Component
- Material Integrity Problem
- Material Split, Cut or Torn
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ATTACHMENT: (B)(4).
Description of Event or Problem
DURING A ROOT CANAL, THE NON-LATEX DENTAL DAM SPLIT AND CAME OFF OVER CLAMP PATIENT WAS UNAWARE OF WHAT HAPPENED. THIS PRODUCT HAS BEEN USED MANY TIMES BEFORE WITHOUT AN ISSUE. ALL PARTS WERE RETRIEVED AND THERE WAS NO HARM TO THE PATIENT.
Remedial action
- Replace