FDA Adverse Event
Injury
Summary report: N
INTEGRITY
MDR report key: 1163090
·
Received September 15, 2008
Report
- Report Number
- 2515379-2008-00082
- Event Type
- Injury
- Date Received
- September 15, 2008
- Report Date
- August 18, 2008
- Manufacturer
- DENTSPLY CAULK
- Product Code
- EBG
- PMA / PMN Number
- K924830
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
WHILE IT IS UNKNOWN IF THE INTEGRITY USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'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 SAME MATERIAL. THEREFORE, THIS EVENT IS REPORTABLE. THE DEVICE WAS NOT RETURNED FOR EVAL AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT HAD A MILD REACTION CHARACTERIZED BY ULCERATION AFTER USE OF INTEGRITY; THE SYMPTOMS WERE TREATED USING A TOPICAL OINTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRITY | EBG | DENTSPLY CAULK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |