ORTHOTIC DEVICE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-08-10 for ORTHOTIC DEVICE manufactured by United Dental Labs.

Event Text Entries

[1360022] My son almost died last weekend due to choking on a flipper, it? S a type of denture, he has two fake front teeth on this. He totally swallowed it, it was stuck in his throat, the heimlich did not work, abdominal thrust loosened it up enough so there was a small airway. After some time, after the paramedics were there he started throwing up and finally threw it up. It was the most horrifying thing to think you are watching your son die in front of you. He has had a flipper for several years, there are no safety clasps on either side of it, no warning by the maker of this product that it is a potential choke hazard. The president of the company called me this morning, he said in his 30 years, no one has ever choked, on their flipper, ok well that? S good, but i also feel no one should ever go through this horrible event again. I want the world to know that this is a possible choke hazard, there should be mandatory safety clasps on all orthotics in the mouth and everyone that has one right now without clasps should get them put on. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5017072
MDR Report Key1802850
Date Received2010-08-10
Date of Report2010-08-10
Date of Event2010-08-07
Date Added to Maude2010-08-19
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameORTHOTIC DEVICE
Generic NameFLIPPER
Product CodeNSK
Date Received2010-08-10
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerUNITED DENTAL LABS


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Deathisabilit 2010-08-10

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