MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-13 for CM3040 manufactured by Collagen Matrix, Inc..
[144935799]
Additional testing of reserve samples met acceptance criteria.
Patient Sequence No: 1, Text Type: N, H10
[144935800]
A distributor advised that a clinician reported to have had a patient come down with an infection. Based on limited correspondence, the clinician may have used portions of one membrane on several patients. As per the ifu, this product is for single use only and open, unused product must be discarded. It is unknown if the product was removed or replaced, or if there was any additional treatment to resolve the reported infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2019-00012 |
| MDR Report Key | 8605932 |
| Date Received | 2019-05-13 |
| Date of Report | 2019-05-10 |
| Date Mfgr Received | 2019-04-15 |
| Device Manufacturer Date | 2018-09-12 |
| Date Added to Maude | 2019-05-13 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 |
| Generic Name | COLLAGEN DENTAL MEMBRANE |
| Product Code | NPL |
| Date Received | 2019-05-13 |
| Model Number | CM3040 |
| Lot Number | CMN18K6 |
| 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 | 2019-05-13 |