MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-10-18 for REGENEROSS RESORBABLE XENOGRAFT ROXR05 manufactured by Collagen Matrix, Inc..
| Report Number | 2249852-2019-00021 |
| MDR Report Key | 9208314 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-10-18 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-04-27 |
| Date Mfgr Received | 2019-09-18 |
| Device Manufacturer Date | 2017-09-30 |
| Date Added to Maude | 2019-10-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. GLORIA ZUCLICH |
| Manufacturer Street | 15 THORNTON ROAD |
| Manufacturer City | OAKLAND NJ 07436 |
| Manufacturer Country | US |
| Manufacturer Postal | 07436 |
| Manufacturer Phone | 2014051477 |
| Manufacturer G1 | COLLAGEN MATRIX, INC. |
| Manufacturer Street | 15 THORNTON ROAD |
| Manufacturer City | OAKLAND NJ 07436 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REGENEROSS RESORBABLE XENOGRAFT |
| Generic Name | PORCINE ANORGANIC BONE MINERAL |
| Product Code | NPM |
| Date Received | 2019-10-18 |
| Catalog Number | ROXR05 |
| Lot Number | PMCU18C4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLLAGEN MATRIX, INC. |
| Manufacturer Address | 15 THORNTON ROAD OAKLAND NJ 07436 US 07436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-18 |