MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-06-30 for MEMBRAGEL 070.101 manufactured by Institut Straumann Ag.
[2099846]
On (b)(6) 2010, use of membragel, 0. 8 ml article number 070. 101, batch y6371 and straumann bone ceramic, 0. 4-0. 7mm, 0. 25g, article 070. 204 batch y8042. Clinician reports on (b)(6) 2011 after using membragel and straumann bone ceramic the pt had pain with loss of membragel. On (b)(6) 2011, buccal swelling with pus - slight pain. On (b)(6) 2011, no swelling and fistula anymore - everything ok. Infection was treated with (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[9284296]
Review of batch records indicate that the product was released according to specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222315-2011-00020 |
| MDR Report Key | 2153285 |
| Report Source | 01,05 |
| Date Received | 2011-06-30 |
| Date of Report | 2011-06-30 |
| Date of Event | 2011-02-10 |
| Date Mfgr Received | 2011-05-31 |
| Date Added to Maude | 2011-07-11 |
| 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 | BARRIER MEMBRANE |
| Product Code | NPK |
| Date Received | 2011-06-30 |
| Catalog Number | 070.101 |
| Lot Number | Y6371 |
| 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 | 2011-06-30 |