MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-10-12 for MEMBRAGEL 070.101 manufactured by Institut Straumann.
[3072188]
A patient received an extensive ridge augmentation in fdi sites 45-47 using autogenous bone, bone substitute material and membrane membragel. Exact date of procedure is not reported. Clinician reported on (b)(6) 2012 that the original op was in (b)(6). Clinician reports that in spite of proactive course of antibiotics and observance of post-operative measures, the patient suffered an extensive infection of the soft tissue. The date of occurrence is not reported. Infection, pain, bleeding, fistula and swelling is reported. The prosthesis was not installed. Further operative treatments were necessary to remove the augumentat. Dates of additional treatments not reported. Clinician reported via telephone on (b)(6) 2012 that the patient had a check-up on (b)(6) 2012 and everything has healed well. The implants are still in place. When the implants were uncovered, the remains of membragel were removed. The soft tissue is without pathological findings.
Patient Sequence No: 1, Text Type: D, B5
[10432808]
Membragel, catalog #070. 101 package insert instructions for use states "treatment outcome is dependent on operative technique and patient response. As with any surgical procedure, infection is a risk. Use sterile intra-operative technique. Do not use at infected sites. 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 | 1222315-2012-00012 |
| MDR Report Key | 2792273 |
| Report Source | 01,05 |
| Date Received | 2012-10-12 |
| Date of Report | 2012-10-12 |
| Date Mfgr Received | 2012-06-26 |
| Device Manufacturer Date | 2010-11-30 |
| Date Added to Maude | 2012-10-17 |
| 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 | 2012-10-12 |
| Catalog Number | 070.101 |
| Lot Number | AY480 |
| Device Expiration Date | 2012-11-30 |
| 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. Required No Informationntervention | 2012-10-12 |