FDA Adverse Event
Injury
Summary report: N
BIOPURE MTAD
MDR report key: 916857
·
Received September 21, 2007
Report
- Report Number
- 2515379-2007-00156
- Event Type
- Injury
- Date Received
- September 21, 2007
- Date of Event
- August 16, 2007
- Report Date
- August 23, 2007
- Manufacturer
- DENTSPLY TULSA
- Product Code
- KJJ
- PMA / PMN Number
- K053167
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
WHILE IT IS UNK IF THE BIOPURE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAMS MATERIAL. THE LOT NUMBER WAS PROVIDED, THOUGH EVALUATION RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT EXPERIENCED SWELLING AND SORENESS IN THE AREA OF A TOOTH IN WHICH BIOPURE WAS USED. THE TOOTH WAS EXTRACTED AS A RESULT OF THE REACTION AND PATIENT DISCOMFORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOPURE MTAD | KJJ | DENTSPLY TULSA | NA | 061201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |