MEMBRAGEL 070.101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-05-23 for MEMBRAGEL 070.101 manufactured by Institut Straumann Ag.

Event Text Entries

[19595751] The batch record review was carried out at the manufacturer and it confirms that the product was within specification. Catalog # 070. 101, membragel, 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. " catalog# 070. 101, membragel, 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. "
Patient Sequence No: 1, Text Type: N, H10


[19663548] (b)(6) 2012, at site 14 implantation with augmentation using bio oss and biogide and membragel 070. 101, (b)(4). (b)(6) 2012, suture ablation - dehiscence with pus, pain and swelling - treated with antibiotics. (b)(6) 2012, pain was worse - removal of augmentate - rinsing with chlorhexidine - new sutures. (b)(6) 2012, rinsing with chlorhexidine - wound was nice and pt did not have pain any more.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222315-2012-00005
MDR Report Key2589796
Report Source01,05
Date Received2012-05-23
Date of Report2012-05-23
Date of Event2012-03-16
Date Mfgr Received2012-04-24
Date Added to Maude2012-06-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactBERNIE MCDONALD
Manufacturer Street60 MINUTEMAN RD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9787472514
Manufacturer G1BIORA AB
Manufacturer StreetMEDEON SCIENCE PARK
Manufacturer CityMALMO
Manufacturer CountrySW
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEMBRAGEL
Generic NameBARRIER MEMBRANE
Product CodeNPK
Date Received2012-05-23
Catalog Number070.101
Lot NumberAP732
Device Expiration Date2013-03-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINSTITUT STRAUMANN AG
Manufacturer AddressBASEL SZ


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-05-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.