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 2012-10-25 for MEMBRAGEL 070.101 manufactured by Institut Straumann.

Event Text Entries

[17347196] Clinician reports that he used membragel together with puros allograft in an augmentation procedure. There was a painful flap overlying the reconstruction site, also flap induration and material removed mucosa returned to normal. The clinician reports that the infected membrane which was placed on (b)(6) 2011 was removed on (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5


[17402660] 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 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


MAUDE Entry Details

Report Number1222315-2012-00015
MDR Report Key2821051
Report Source01,05
Date Received2012-10-25
Date of Report2012-10-25
Date of Event2011-12-20
Date Mfgr Received2012-03-21
Device Manufacturer Date2011-02-01
Date Added to Maude2012-11-07
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 Received2012-10-25
Catalog Number070.101
Lot NumberAW195
Device Expiration Date2013-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINSTITUT STRAUMANN
Manufacturer AddressBASEL SZ


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-10-25

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