ETM FLUSH CUT DISTAL-END CUTTER WITH SAFETY HOLD
Received Dec 9, 2016
Report 2016150-2016-00007 · MDR key 6159692
Device
Product problems
- Failure To Adhere Or Bond
- Device Dislodged or Dislocated
Patient
Not reported
- Injury
- Injury
Narrative
Additional Manufacturer Narrative
IT WAS ALLEGED THAT A PATIENT WAS SENT TO AN ORAL SURGEON AND SURGICAL INTERVENTION MAY HAVE BEEN REQUIRED; HOWEVER NO FURTHER SPECIFIC INFORMATION HAS BEEN RECEIVED AT THIS TIME. AN UPDATE WILL BE PROVIDED UPON RECEIPT OF NEW INFORMATION.
Description of Event or Problem
IT WAS ALLEGED THAT A PATIENT WAS SENT TO AN ORAL SURGEON TO REMOVE DISTAL END THAT DID NOT HOLD AND LODGED INTO PATIENTS CHEEK.
Additional Manufacturer Narrative
IT WAS ALLEGED THAT A PATIENT WAS SENT TO AN ORAL SURGEON AND SURGICAL INTERVENTION MAY HAVE BEEN REQUIRED; HOWEVER NO FURTHER SPECIFIC INFORMATION HAS BEEN RECEIVED. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE COMPLAINANT ON 11/15/2016, 11/16/2016, 11/30/2016, AND 12/05/2016 IN ORDER TO OBTAIN FURTHER INFORMATION; HOWEVER, THE COMPLAINANT HAS REMAINED UNRESPONSIVE. NO FURTHER INFORMATION HAS BEEN RECEIVED TO SUGGEST THAT A SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.
Description of Event or Problem
IT WAS ALLEGED THAT A PATIENT WAS SENT TO AN ORAL SURGEON AND SURGICAL INTERVENTION MAY HAVE BEEN REQUIRED; HOWEVER NO FURTHER SPECIFIC INFORMATION HAS BEEN RECEIVED.