MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2013-06-08 for NUOSS XC 509-2001 manufactured by Collagen Matrix, Inc..
[15933414]
Patient claims that hives developed on neck, chest, and arms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2013-00003 |
| MDR Report Key | 3177544 |
| Report Source | 05,08 |
| Date Received | 2013-06-08 |
| Date of Report | 2013-04-27 |
| Date of Event | 2013-03-27 |
| Date Mfgr Received | 2013-03-27 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2013-06-20 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 |
| Generic Name | BONE GRAFTING MATERIAL |
| Product Code | NPM |
| Date Received | 2013-06-08 |
| Model Number | 509-2001 |
| Lot Number | BMCPU09M1 |
| Device Expiration Date | 2012-10-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-08 |