MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-07-18 for NUOSS GRANULES BMC20010 509-9004 manufactured by Collagen Matrix, Inc..
[4822815]
Patient experienced gross inflammatory reaction, and the bone graft material was removed 2 weeks after placement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2014-00004 |
| MDR Report Key | 3980830 |
| Report Source | 08 |
| Date Received | 2014-07-18 |
| Date of Report | 2014-04-25 |
| Date of Event | 2014-03-13 |
| Date Mfgr Received | 2014-04-21 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2014-08-06 |
| 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 GRANULES |
| Generic Name | BONE GRAFT MATERIAL |
| Product Code | NPM |
| Date Received | 2014-07-18 |
| Model Number | BMC20010 |
| Catalog Number | 509-9004 |
| Lot Number | BMCU12P3 |
| Device Expiration Date | 2016-01-31 |
| 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 | 2014-07-18 |