MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-09-14 for MEMBRAGEL 070.101 manufactured by Institut Straumann Ag.
[2195043]
Implantation of implant article number 033. 653s, lot ak316 with ridge augmentation using biooss (b)(4), lot 11033 and membragel 0. 8 ml lot an688 on (b)(6), 2011. Only the augmentation material was removed on (b)(6), 2011. The implant was stable. Clinician reports that the pt had pain and swelling infection.
Patient Sequence No: 1, Text Type: D, B5
[9346379]
The batch record review has been carried out and confirms that the product was mfg and released according to specs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222315-2011-00036 |
| MDR Report Key | 2251463 |
| Report Source | 01,05 |
| Date Received | 2011-09-14 |
| Date of Report | 2011-09-14 |
| Date of Event | 2011-08-15 |
| Date Mfgr Received | 2011-08-16 |
| Date Added to Maude | 2011-09-19 |
| 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 | 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 | BARRIER MEMBRANE |
| Product Code | NPK |
| Date Received | 2011-09-14 |
| Catalog Number | 070.101 |
| Lot Number | AN688 |
| Device Expiration Date | 2012-11-30 |
| 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 | 2011-09-14 |