MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-10 for MEMBRAGEL 070.101 manufactured by Instiut Straumann.
[3363735]
The clinician reports that a patient had a dental treatment on (b)(6) 2013 to treat a peri-implant bone defect and lateral ridge augmentation in bone quality type iv using lifenet bone graft, cortical bone and membragel. On (b)(6) 2013 the clinician reports that there was inflammation, purulent drainage, extrusion of membrane, wound breakdown. The clinician reports that at the time of the event, the patient suffered from pain, bleeding, fistula, abscess, swelling and inflammation. The clinician reports no response to antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[10602259]
Membragel, catalog #070. 101 package insert instructions for use state "treatment outcome is dependant 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. " 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. Based on the information provided the lot number ay481 was used by the clinician after the expiry date that is printed on the membragel package label. Review of the lot tracking reports for membragel catalog #070. 101 lot ay481 show that all units of lot ay481 were sold within our specified shipping times in respect to the expiry date. The review showed that straumann did not distribute this article, lot number ay481, to this clinician. Our investigation indicates that this clinician acquired the article 070. 101 lot ay481 from a source other than straumann. 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 | 1222315-2013-00002 |
| MDR Report Key | 3057257 |
| Report Source | 05 |
| Date Received | 2013-04-10 |
| Date of Report | 2013-04-10 |
| Date of Event | 2013-03-04 |
| Date Mfgr Received | 2013-03-14 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2013-04-16 |
| 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 | 2013-04-10 |
| Catalog Number | 070.101 |
| Lot Number | AY481 |
| 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 | INSTIUT STRAUMANN |
| Manufacturer Address | BASEL SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-10 |