FDA Adverse Event
Other
Summary report: N
NUOSS
MDR report key: 2591898
·
Received May 18, 2012
Report
- Report Number
- 2249852-2012-00002
- Event Type
- Other
- Date Received
- May 18, 2012
- Date of Event
- August 18, 2012
- Report Date
- March 10, 2012
- Manufacturer
- COLLAGEN MATRIX, INC.
- Product Code
- NPM
- PMA / PMN Number
- K043034
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
INFECTION. EXTRACTION SOCKET REGRAFTED AFTER DEBRIDEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUOSS | ANORGANIC BONE MINERAL | NPM | COLLAGEN MATRIX, INC. | BMC2510 | BMCU08C5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |