MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-09-16 for MEMBRAGEL 070.101 manufactured by Institut Straumann Ag.
[2160629]
Clinician reports augmentation surgery with bone ceramic and membragel in region 11 on (b)(6) 2010. On (b)(6) 2011, a fistula developed. The membragel membrane was removed on (b)(6) 2011. The membragel could be removed in fragments. The bone ceramic was not affected. The infection was successfully treated. Pt is a smoker.
Patient Sequence No: 1, Text Type: D, B5
[9331581]
The batch record review has been carried out and confirms that the product was within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222315-2011-00040 |
| MDR Report Key | 2256886 |
| Report Source | 01,05 |
| Date Received | 2011-09-16 |
| Date of Report | 2011-09-16 |
| Date of Event | 2011-03-30 |
| Date Mfgr Received | 2011-08-17 |
| Date Added to Maude | 2011-09-22 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BERNIE MCDONALD |
| Manufacturer Street | 60 MINUTEMANN RD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787472514 |
| Manufacturer G1 | BIORA AB |
| Manufacturer Street | MEDEON SCIENCE PARK |
| Manufacturer City | MALMO |
| Manufacturer Country | SW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEMBRAGEL |
| Generic Name | BARRIER MEMBRANE |
| Product Code | NPK |
| Date Received | 2011-09-16 |
| Catalog Number | 070.101 |
| Lot Number | Y9146 |
| Device Expiration Date | 2011-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSTITUT STRAUMANN AG |
| Manufacturer Address | BASEL SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-16 |