MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-23 for BIOMEND 0103Z manufactured by Collagen Matrix, Inc..
[118252920]
Following several attempts, collagen matrix, inc. Was not able to obtain product lot specific identifers (i. E. Lot number, expiration date), therefore, a full investigation could not be completed.
Patient Sequence No: 1, Text Type: N, H10
[118252921]
The doctor reported during routine follow-up visit, one week after the initial implantation of the membrane, the membrane was gone. Typical product resorption as indicated in the instructions for use is approximately 8 weeks. The clinician performed a follow-up surgical intervention to re-graft the site with another membrane
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2018-00008 |
| MDR Report Key | 7810302 |
| Date Received | 2018-08-23 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-06-21 |
| Date Mfgr Received | 2018-08-07 |
| Date Added to Maude | 2018-08-23 |
| 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 | BIOMEND |
| Generic Name | COLLAGEN DENTAL MEMBRANE |
| Product Code | NPL |
| Date Received | 2018-08-23 |
| Model Number | 0103Z |
| 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 | 2018-08-23 |