MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-11-22 for RCT RESORBABLE COLLAGEN TAPE 509-1000 manufactured by Collagen Matrix, Inc..
[92805481]
Collagen matrix, inc. Was informed that the product rct resorbable collagen tape was used past the product's established shelf life. Collagen matrix, inc. Cannot guarantee product performance or sterility past the established shelf life.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2017-00021 |
| MDR Report Key | 7054338 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-11-22 |
| Date of Report | 2017-11-22 |
| Date of Event | 2017-10-19 |
| Date Mfgr Received | 2017-10-23 |
| Device Manufacturer Date | 2012-12-02 |
| Date Added to Maude | 2017-11-22 |
| 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 | RCT RESORBABLE COLLAGEN TAPE |
| Generic Name | COLLAGEN DENTAL WOUND DRESSING |
| Product Code | LYC |
| Date Received | 2017-11-22 |
| Catalog Number | 509-1000 |
| Lot Number | DWTN12M1 |
| Device Expiration Date | 2015-12-31 |
| Operator | PHYSICIAN |
| 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 | 2017-11-22 |