MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-07-02 for MEMBRAGEL 070.101 manufactured by Institut Strauman Ag.
[2869674]
Clinician reports disturbance of wound healing. No loss of dental implant only disturbance of wound healing after membragel. Clinician reports an implantation took place on (b)(6), 2011 in sites 14 and 15 and augmented with bone ceramic 070. 204 lot z0666 and membragel 070. 101 al0777. Bone chips were collected through filter plus chips from buccal site 16 were mixed with bone ceramic. Membragel was then applied. (b)(6) prescribed. On (b)(6), 2011 pt reports hardly any pain or swelling. On (b)(6), 2011 there was a suture dehiscence. Doxyline was prescribed. On (b)(6), 2011 there was a massive suture dehiscence from site 13 - 16. Ponstan and dafalgan were prescribed. On (b)(6), 2011 (b)(6) and doxyline prescribed. At appointment on (b)(6), 2011 the pt had no spontaneous pain. On (b)(6), 2012 there were no complications. On (b)(6), 2012 there was a fistula in site 13. The bone ceramic was removed, the site rinsed and cleaned. An oral surgeon will carry out a buccal bone augmentation at a later stage.
Patient Sequence No: 1, Text Type: D, B5
[10069451]
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 infection 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
| Report Number | 1222315-2012-00007 |
| MDR Report Key | 2644348 |
| Report Source | 01,05 |
| Date Received | 2012-07-02 |
| Date of Report | 2012-06-29 |
| Date of Event | 2012-01-31 |
| Date Mfgr Received | 2012-05-30 |
| Date Added to Maude | 2012-07-10 |
| 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 | 2012-07-02 |
| Model Number | 070.101 |
| Lot Number | AL077 |
| Device Expiration Date | 2012-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSTITUT STRAUMAN AG |
| Manufacturer Address | BASEL SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-02 |