MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-05-12 for NUOSS XC SINUS BMCU22 509-3002 manufactured by Collagen Matrix, Inc..
[4503036]
Pt implanted with bone grafting material experienced sinus infection. The product was removed, allowing the pt to heal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2014-00003 |
| MDR Report Key | 3836151 |
| Report Source | 08 |
| Date Received | 2014-05-12 |
| Date of Report | 2014-05-01 |
| Date of Event | 2013-12-12 |
| Date Mfgr Received | 2014-04-01 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2014-05-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PEGGY HANSEN |
| Manufacturer Street | 15 THORNTON ROAD |
| Manufacturer City | OAKLAND NJ 07436 |
| Manufacturer Country | US |
| Manufacturer Postal | 07436 |
| Manufacturer Phone | 2014051477 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUOSS XC SINUS |
| Generic Name | BONE GRAFT MATERIAL |
| Product Code | NPM |
| Date Received | 2014-05-12 |
| Model Number | BMCU22 |
| Catalog Number | 509-3002 |
| Lot Number | BMCXU11H2 |
| Device Expiration Date | 2014-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLLAGEN MATRIX, INC. |
| Manufacturer Address | OAKLAND NJ 07436 US 07436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-12 |