MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-07-30 for MEMBRAGEL 070.101 manufactured by Institut Straumann.
[2777196]
Clinician reports that a sinus lift treatment was carried out on the pt on (b)(6) 2012 using membragel and bone ceramic. The operation was uneventful. The clinician reports that the pt suffered a huge swelling and extreme pain during the wound healing period. The clinician reports there was a dehiscence on (b)(6) 2012. The membragel was removed and the site was rinsed and the dehiscence covered. The bone appears to be stable.
Patient Sequence No: 1, Text Type: D, B5
[10086077]
Membragel, catalog #070. 101, package insert instructions for use state "treatment outcome is dependent on operative technique and pt response. As with any surgical procedure, infection is a risk. Use sterile intra-operative technique. Do not use at infected sites. " membragel, catalog #070. 101, package insert instructions for use state "the following complications are common with the surgical intervention with barrier membranes and therefore may not be totally excluded: soft tissue dehiscence, hematoma, pain, inflammation, increased sensitivity and redness. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222315-2012-00010 |
| MDR Report Key | 2678549 |
| Report Source | 01,05 |
| Date Received | 2012-07-30 |
| Date of Report | 2012-07-30 |
| Date of Event | 2012-07-03 |
| Date Mfgr Received | 2012-07-06 |
| Device Manufacturer Date | 2011-02-01 |
| Date Added to Maude | 2012-08-03 |
| 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 | 2012-07-30 |
| Catalog Number | 070.101 |
| Lot Number | AX183 |
| Device Expiration Date | 2013-02-28 |
| 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 |
| Manufacturer Address | BASEL SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-30 |