MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-09-14 for MEMBRAGEL 070.101 manufactured by Institut Straumann Ag.
[2194190]
On (b)(6) 2011, surgery with use of membragel, 0. 8 ml article number 070. 101, batch z5930 and strauman bone ceramic, 0. 4-0. 7mm, 0. 25g, article 070. 203, batch y8040. Clinician reports on (b)(6) 2011, after using membragel and bone ceramic the pt had fistula, abcess and infecton discovered on (b)(6) 2011. Clinician reports that after consultation with another clinician, the clinician had to remove the membragel and augmentation material and redo the augmentation in the upper front area. The pt bleed strongly during the surgery. The clinician suspects that due to that a haematoma was formed which became infected.
Patient Sequence No: 1, Text Type: D, B5
[9331432]
Review of batch records indicate that the product was released according to specs. The info from the customer that they had complications with membragel was first reported to the mfr sales person on (b)(4) 2011 and was recorded in the salesperson's report of this date. However, the info was not passed on to the complaint handling officers until august 19, 2011, which is the date that the complaint was recorded and escalated to the product safety officer. This is the reason for the delay between the date received by mfr, (b)(4) 2011 and the date of this report, 09/14/2011. When evaluating the complaint file including the further add'l info provided by the customer on sep 7, 2011, the product safety officer determined this discrepancy. The mfr sales organization received a separate training on august 26, 2011 to address this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222315-2011-00034 |
| MDR Report Key | 2251460 |
| Report Source | 01,05 |
| Date Received | 2011-09-14 |
| Date of Report | 2011-09-14 |
| Date of Event | 2011-03-02 |
| Date Mfgr Received | 2011-03-07 |
| Date Added to Maude | 2011-09-19 |
| 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 | 3 |
| 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 | 2011-09-14 |
| Catalog Number | 070.101 |
| Lot Number | Z5930 |
| Device Expiration Date | 2012-05-31 |
| 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. Required No Informationntervention | 2011-09-14 |