MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-09-05 for MEM-LOK RCM-ML3040 manufactured by Collagen Matrix, Inc..
[119254353]
As indicated in the instructions for use, infection is a known inherent risk associated with any surgical procedure. Reserve sample testing confirmed that the product met release criteria.
Patient Sequence No: 1, Text Type: N, H10
[119254354]
The clinician reported that 10 days following initial dental procedure a surgical site infection was observed and required follow-up procedure to remove the membrane. Upon re-entry of the surgical site the clinician observed that the membrane was "gone". Primary closure was attained and sutures were intact prior to follow-up procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2018-00012 |
| MDR Report Key | 7847186 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-09-05 |
| Date of Report | 2018-09-05 |
| Date Mfgr Received | 2018-08-09 |
| Device Manufacturer Date | 2017-09-27 |
| Date Added to Maude | 2018-09-05 |
| 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 | 3 |
| Brand Name | MEM-LOK |
| Generic Name | COLLAGEN DENTAL MEMBRANE |
| Product Code | NPL |
| Date Received | 2018-09-05 |
| Catalog Number | RCM-ML3040 |
| Lot Number | CMN17L2 |
| 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 | 2018-09-05 |