FDA Adverse Event
Injury
Summary report: N
DENTAL DAM CLAMP 12A
MDR report key: 2516298
·
Received March 29, 2012
Report
- Report Number
- 2523190-2012-00031
- Event Type
- Injury
- Date Received
- March 29, 2012
- Report Date
- March 29, 2012
- Manufacturer
- INTEGRA YORK, PA INC
- Product Code
- EMJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
"PRODUCT CLAMP SNAPPED ON FIRST USE." ON (B)(6) 2012, THE DENTAL ASSISTANT REPORTED THAT DURING A RESTORATIVE COMPOSITE BONDING PROCEDURE PERFORMED ABOUT 2 WEEKS AGO, THE DEVICE "SNAPPED" ON THE PT'S GUMS CAUSING SOME GINGIVAL TRAUMA THAT WAS TREATED WITH SOFT TISSUE LASER THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DENTAL DAM CLAMP 12A | M51-GENERAL DENTISTRY | EMJ | INTEGRA YORK, PA INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Required Intervention |