FDA Adverse Event
Malfunction
Summary report: N
ADSN TISS FCPS 4-3/4 1X2
MDR report key: 3958804
·
Received June 26, 2014
Report
- Report Number
- 2523190-2014-00047
- Event Type
- Malfunction
- Date Received
- June 26, 2014
- Date of Event
- June 2, 2014
- Report Date
- June 12, 2014
- Manufacturer
- INTEGRA YORK, PA INC.
- Product Code
- EKD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
CUSTOMER INITIALLY REPORTS TEETH BROKE WHILE TREATING PT. ON (B)(6) 2014, CUSTOMER REPORTS TIP FROM THE ONE TOOTH SIDE OF FORCEP BROKE OFF IN PT LIP WHEN A BIOPSY WAS BEING TAKEN. TIP WAS REMOVED EASILY. NO HARM TO PT. EVENT DATE NOT AVAILABLE, (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 373414 | ADSN TISS FCPS 4-3/4 1X2 | M5-GENERAL SURGERY | EKD | INTEGRA YORK, PA INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |