ORTHODONTIC WIRE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-06 for ORTHODONTIC WIRE manufactured by .

Event Text Entries

[5670505] My son, (b)(6), finished orthodontic treatment about 3 years ago, and was fitted with a small orthodontic wire, glued to the back of his front teeth, in order to prevent the teeth from migrating back to the original space. This was done by a very professional orthodontist, who uses only fda-approved materials and devices. A few days ago he was admitted to the hospital with extreme abdominal pain. Sonogram and ct imaging could not pick up anything, but his blood work indicated a severe infection. A second ct scan, done 4 days later, revealed a life-threatening puncture and infection of the stomach wall. During surgery, a thin wire - identified as an orthodontic wire, was pulled out: it had punctured the whole stomach wall - side to side. He is now hospitalized, getting 5 types of antibiotics (iv, obviously - he can't use his digestive system yet). I don't know who to contact in order to prevent this from happening to someone else, so i'm writing to you. I have the wire extracted from his stomach, and the orthodontist confirmed this was the wire used in his mouth. I can also supply ct images of the wire stuck in the stomach wall.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5042072
MDR Report Key4684409
Date Received2015-04-06
Date of Report2015-04-06
Date of Event2015-04-01
Date Added to Maude2015-04-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameORTHODONTIC WIRE
Generic NameORTHODONTIC WIRE
Product CodeDZC
Date Received2015-04-06
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening 2015-04-06

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