FDA Adverse Event
Injury
Summary report: N
5 X 5 GREEN THIN READY CUT DAM
MDR report key: 3415716
·
Received October 11, 2013
Report
- Report Number
- 2416455-2013-00001
- Event Type
- Injury
- Date Received
- October 11, 2013
- Date of Event
- September 12, 2013
- Report Date
- October 11, 2013
- Manufacturer
- COLTENE/WHALEDENT INC.
- Product Code
- EIE
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION CONTINUES AS THIS REPORT IS BEING WRITTEN.
Description of Event or Problem · 1
ANAPHYLAXIS REACTION. PATIENT WAS TAKEN TO THE HOSPITAL BY AN AMBULANCE AND ADMITTED BY A DOCTOR, HOWEVER SHE WAS DISCHARGED FROM THE HOSPITAL NEXT DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 521584 | 5 X 5 GREEN THIN READY CUT DAM | DENTAL DAM | EIE | COLTENE/WHALEDENT INC. | H02141 | 27901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Hospitalization | FORCEPS FOR A RUBBER DAM CLAMP| BUR FOR REMOVING CERAMIC AND SOFTENED DENTIN| (DATE OF TX: (B)(6) 2013)| RUBBER DAM FRAME| (DATE OF TX: (B)(6) 2013)| (DATE OF TX: (B)(6) 28/2013)| FILTEK SUPREME ULTRA A4 (3M ESPE) FOR PULP CAPPING| (DATE OF TX: (B)(6) 2013)| (DATE OF TX: (B)(6) 2013)| (DATE OF TX: (B)(6) 2013)| PRIMING| BONDING| (DATE OF TX: (B)(6) 2013)| CARIES CHECK| (DATE OF TX: (B)(6) 2013)| RUBBER DAM CLAMP |