SEA-BOND DENTURE ADHESIVE UPPER WAFERS
Received Nov 25, 2009 · Event occurred Sep 28, 2009
Report 1450238-2009-00001 · MDR key 1546840
Device
Manufacturer
Combe Inc.Lot number
R09B133
Product problems
- Improper or Incorrect Procedure or Method
Patient
80 YR
- Stroke/CVA
- Choking
Narrative
Description of Event or Problem
INITIAL REPORTER STATED THAT HE BELIEVES THAT HIS WIFE, WHO HAS BEEN RECOVERING FROM A HEART ATTACK IN A HOSP IN 2009, CHOKED ON SEA BOND DENTURE ADHESIVE WAFERS RESULTING IN A STROKE. THE REPORTER SAID THAT HE WAS NOT PRESENT WHEN A HOSP ATTENDANT MISAPPLIED THE SEA BOND ADHESIVE TO HIS WIFE'S DENTURES BY USING 2 OR 3 UNCUT WAFERS TO COMPENSATE FOR HER ILL-FITTING DENTURES. HE SAID THAT AS THE HOSP STAFF ATTEMPTED TO CLEAR THE EXCESS ADHESIVE FROM HER MOUTH/THROAT, SHE SUFFERED A STROKE AND REMAINS IN THE HOSP.
Additional Manufacturer Narrative
UNABLE TO GET ANY FURTHER INFO FROM THE INITIAL REPORTER INCLUDING UNUSED PRODUCT AND MEDICAL RECORDS SUBSTANTIATING THE STROKE IN SPITE OF ATTEMPTS TO REACH HIM BY PHONE AND MAIL. RESULTS OF EVALUATION OF RETAINED SAMPLE AND BATCH RECORDS OF LOT R09B133 SHOW NO ISSUES THAT SUGGEST ANY DEFECTS ASSOCIATED WITH THE LOT.