MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-12-27 for NUOSS CANCELLOUS manufactured by Collagen Matrix, Inc..
[95835366]
Patient experienced swelling within 24 hours of procedure, no infection was observed. The patient received antibiotics, pain medication and mouthwash. The symptoms subsided within 1 week.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2017-00023 |
| MDR Report Key | 7148264 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-12-27 |
| Date of Report | 2017-12-27 |
| Date Mfgr Received | 2017-11-28 |
| Device Manufacturer Date | 2015-11-22 |
| Date Added to Maude | 2017-12-27 |
| 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 | 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 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 | NUOSS CANCELLOUS |
| Generic Name | OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS |
| Product Code | NPM |
| Date Received | 2017-12-27 |
| Lot Number | BM2CU15K1 |
| Device Expiration Date | 2018-11-30 |
| Operator | DENTIST |
| 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. Required No Informationntervention | 2017-12-27 |