MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-10-25 for MEMBRAGEL 070.101 manufactured by Institut Straumann.
[17347196]
Clinician reports that he used membragel together with puros allograft in an augmentation procedure. There was a painful flap overlying the reconstruction site, also flap induration and material removed mucosa returned to normal. The clinician reports that the infected membrane which was placed on (b)(6) 2011 was removed on (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
[17402660]
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. " the manufacturer carried out a review of the batch record documentation and confirms that the product was released according to specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222315-2012-00015 |
| MDR Report Key | 2821051 |
| Report Source | 01,05 |
| Date Received | 2012-10-25 |
| Date of Report | 2012-10-25 |
| Date of Event | 2011-12-20 |
| Date Mfgr Received | 2012-03-21 |
| Device Manufacturer Date | 2011-02-01 |
| Date Added to Maude | 2012-11-07 |
| 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 | 2012-10-25 |
| Catalog Number | 070.101 |
| Lot Number | AW195 |
| Device Expiration Date | 2013-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2012-10-25 |