MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-08-22 for MEMBRAGEL 070.101 manufactured by Institut Straumann.
[16747362]
Clinician reports that a dental implantation with 2 thomen implants in sites fdi 46 and 47 was carried out on (b)(6) 2012. At the same time the sites were augmented using straumann bone ceramic 070. 204 lot t9017 and membragel 070. 101 lot ay440. There were no difficulties during the op and the clinician was very satisfied with the results. At the check-up appointment on (b)(6) 2012, the pt reports pain and that the site has been swollen since 1 day after the op. The clinician reports that there was a wound dehiscence and the wound was very sensitive. Pt reports much pain since 3 days, dalacin c (antibiotic) was prescribed. The clinician reports that the pt canceled the appointment on (b)(6) 2012 when it was intended to remove the sutures. The pt stated on approx (b)(6) 2012, that the reason for the cancellation was that the pain had been too much and had lost 3 kg in weight so he went to another dentist who prescribed another course of antibiotics, strong painkillers and appears to have removed everything. Exact date of treatment is not known. Pt will not give any details about the other dentist. Clinician contacted the pt on (b)(6) 2012 and the pt reports that things are better.
Patient Sequence No: 1, Text Type: D, B5
[17085309]
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 mfr carried out a review of the batch record documentation and confirms that the product was released according to spec.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222315-2012-00011 |
| MDR Report Key | 2713956 |
| Report Source | 01,05 |
| Date Received | 2012-08-22 |
| Date of Report | 2012-08-22 |
| Date of Event | 2012-07-10 |
| Date Mfgr Received | 2012-07-27 |
| Device Manufacturer Date | 2011-02-01 |
| Date Added to Maude | 2012-08-27 |
| 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 | 2012-08-22 |
| Catalog Number | 070.101 |
| Lot Number | AY440 |
| 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 | 2012-08-22 |