FDA Adverse Event Other Summary report: N

MATERIAL OBTAINED FROM DENTIST

MDR report key: 403198 · Received July 3, 2002

Report

Report Number
MW1025490
Event Type
Other
Date Received
July 3, 2002
Date of Event
May 10, 2002
Report Date
July 2, 2002
Manufacturer
UNK
Product Code
ELW
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

PERMANENT DENTAL BRIDGE PLACED OVER IMPLANTS. WITHIN HRS DEVELOPED ULCERS UNDER TONGUE AND ON LIP TOGETHER WITH A VERY PAINFUL AND INFLAMED THROAT WHICH MADE SWALLOWING DIFFICULT.

Description of Event or Problem · 1

ADD'L INFO REC'D FROM MFR ON 07/03/2002: ACRYLIC DENTAL IMPRESSION MATERIAL USED FOR BRIDGE CONSTRUCTION. THERE WERE ONGOING VISITS PRIOR TO BRIDGE INSERTION. BRIDGE WAS REMOVED & BOILD TO TRY TO REMOVE ALLERGIC PROPERTIES AND REINSERTED. ULCERS AND THROAT INFLAMMATION REAPPEARED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MATERIAL OBTAINED FROM DENTIST DENTAL BRIDGE ELW UNK NI NI

Patients

Seq Age Sex Outcome Treatment
1 68 YR Other MATERIAL.| PARTIAL BRIDGE WHICH PT NEVER WORE IS OF SAME