MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-07 for OSTEOSHIELD OSCRM1520 manufactured by Collagen Matrix, Inc..
[61698410]
Investigation could not be completed. Collagen matrix, inc. Could not obtain the product lot number and/or expiration date, therefore further assessment could not be performed.
Patient Sequence No: 1, Text Type: N, H10
[61698411]
Clinician observed a foreign body reaction with the use of the membrane. The clinician thought it was caused by the membrane but also mentioned patient born and surgically born issues may have led to what was observed. Complaint states that the patient was not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2016-00018 |
| MDR Report Key | 6153417 |
| Date Received | 2016-12-07 |
| Date of Report | 2016-12-07 |
| Date Mfgr Received | 2016-11-09 |
| Date Added to Maude | 2016-12-07 |
| 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 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 | 0 |
| Brand Name | OSTEOSHIELD |
| Generic Name | COLLAGEN DENTAL MEMBRANE |
| Product Code | NPL |
| Date Received | 2016-12-07 |
| Catalog Number | OSCRM1520 |
| 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. Other | 2016-12-07 |