MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-09-16 for MEMBRAGEL 070.101 manufactured by Institut Straumann Ag.
[2195592]
Clinician reports surgery on (b)(6) 2011 in region 36 using membragel and bone ceramic. On (b)(6) 2011, there was loss of membragel. Bone ceramic is not affected. The membrane was exposed, degradation material was exuded. Infection was successfully treated.
Patient Sequence No: 1, Text Type: D, B5
[9349749]
The batch record review has been carried out and confirms that the product was within specification.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1222315-2011-00039 |
MDR Report Key | 2256887 |
Report Source | 01,05 |
Date Received | 2011-09-16 |
Date of Report | 2011-09-16 |
Date of Event | 2011-05-29 |
Date Mfgr Received | 2011-08-17 |
Date Added to Maude | 2011-09-22 |
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 MINUTEMANN 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 | 2011-09-16 |
Catalog Number | 070.101 |
Lot Number | Z5930 |
Device Expiration Date | 2012-05-31 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
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 | 2011-09-16 |