MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-05-23 for MEMBRAGEL 070.101 manufactured by Institut Straumann Ag.
[19595751]
The batch record review was carried out at the manufacturer and it confirms that the product was within specification. Catalog # 070. 101, membragel, 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. " catalog# 070. 101, membragel, 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
[19663548]
(b)(6) 2012, at site 14 implantation with augmentation using bio oss and biogide and membragel 070. 101, (b)(4). (b)(6) 2012, suture ablation - dehiscence with pus, pain and swelling - treated with antibiotics. (b)(6) 2012, pain was worse - removal of augmentate - rinsing with chlorhexidine - new sutures. (b)(6) 2012, rinsing with chlorhexidine - wound was nice and pt did not have pain any more.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1222315-2012-00005 |
MDR Report Key | 2589796 |
Report Source | 01,05 |
Date Received | 2012-05-23 |
Date of Report | 2012-05-23 |
Date of Event | 2012-03-16 |
Date Mfgr Received | 2012-04-24 |
Date Added to Maude | 2012-06-06 |
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 | 2012-05-23 |
Catalog Number | 070.101 |
Lot Number | AP732 |
Device Expiration Date | 2013-03-28 |
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 AG |
Manufacturer Address | BASEL SZ |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2012-05-23 |