FDA Adverse Event
Injury
Summary report: N
15X20MM BIOMEND
MDR report key: 2452650
·
Received February 10, 2012
Report
- Report Number
- 1121308-2012-00006
- Event Type
- Injury
- Date Received
- February 10, 2012
- Date of Event
- August 10, 2011
- Report Date
- February 10, 2012
- Manufacturer
- INTEGRA LIFESCIENCES CORP.
- Product Code
- LYC
- PMA / PMN Number
- K924408
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE REPORTER STATED THAT DURING A DENTAL PROCEDURE, IT WAS OBSERVED THAT THE BIOMEND CONSISTENCY WAS STIFF; IT WAS HARD TO MOLD. THERE WAS POOR WOUND HEALING AND THE PT DEVELOPED AN INFECTION, SWELLING AND DISCOMFORT AT TOOTH NUMBER 14. THE PT'S CONDITION IS REPORTED TO BE FAIR. NO OTHER INFO WAS PROVIDED BY THE REPORTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 15X20MM BIOMEND | DENTAL PRODUCTS | LYC | INTEGRA LIFESCIENCES CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |