MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-01-06 for MEMBRAGEL 070.101 manufactured by Institut Straumann Ag.
[2412775]
Bone augmentation without implantation on (b)(6) 2010 regio 44. Bone ceramic 070. 203 lot y8039 and membragel 070. 101, lot y6371 perio cut, area stress-free. On (b)(6) 2010, patient has swelling in area. On (b)(6) 2010, little pain but swelling, wound healing well without dehiscence, suture removal. On (b)(6) 2010, fistula, dehiscence, liquid exuding, point-shaped dehiscence, some swelling, pus, pain under pressure nacl-solution rinsed via dehiscence, rest of wound in ice. On (b)(6) 1010, better, less liquid out of dehiscence, rinsing. On (b)(6) 2010, still unclear rinsing. On (b)(6) 2010, rinsing, dehiscence still open, liquid secretion during rinsing, rinsing with nacl. On (b)(6) 2010, removal of complete construction, rinsing with nacl. On (b)(6) 2011, perforation of corticalis, augmentation using bio oss and bio gide (geistlich). On (b)(b) 2011, nice wound healing, no inflammation, removal of suture. On (b)(6) 2011, no swelling or redness. On (b)(6) 2011, mouth hygiene not optimal, a lot of plaque. On (b)(6) 2011, implantation regio 44 with implant 033. 52s lot ap054. On (b)(6) 2011, well and nice wound healing, osstell measurement good.
Patient Sequence No: 1, Text Type: D, B5
[9594827]
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 | 1222315-2012-00001 |
| MDR Report Key | 2406178 |
| Report Source | 01,05 |
| Date Received | 2012-01-06 |
| Date of Report | 2012-01-06 |
| Date of Event | 2010-12-03 |
| Date Mfgr Received | 2011-12-08 |
| Date Added to Maude | 2012-01-12 |
| 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 MINUTEMAN 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 | NPK - BARRIER MEMBRANE |
| Product Code | NPK |
| Date Received | 2012-01-06 |
| Catalog Number | 070.101 |
| Lot Number | Y6371 |
| Device Expiration Date | 2011-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2012-01-06 |