STRAUMANN EMDOGAIN 075.114

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 2015-01-09 for STRAUMANN EMDOGAIN 075.114 manufactured by Biora Ab.

Event Text Entries

[5414162] Clinician reports lack of wound healing after a periodontal surgery to treat an intraosseous/furcation defect which was performed on (b)(6) 2014. Treatment site: fdi #21 - mp intrabony defect (5 mm intrabony component). Surgical technique was minimally invasive. On (b)(6) 2014 post-op symptoms included severe pain and discomfort with signs as severe swelling and necrosis. The clinician suspects an allergic reaction to the product.
Patient Sequence No: 1, Text Type: D, B5


[12921618] The review of the risk management report "risk mgmt report - emd prefgel osteogain (b)(4) version 1. 0" confirms that incautious use in patients pre-disposed to allergic reactions is assessed and reflected in the ifu labelling 700019 straumann emdogain (us version). A previous evaluation by an allergist states that the allergy potential of emdogain is very low. The manufacturer reviewed manufacturing batch records for both 075. 114 lot gp625 (both emdogain and prefgel) and confirms that the product was released according to specification.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1222315-2015-00002
MDR Report Key4433297
Report Source01,05
Date Received2015-01-09
Date of Report2015-01-08
Date of Event2014-10-07
Date Mfgr Received2014-11-04
Device Manufacturer Date2013-09-01
Date Added to Maude2015-02-03
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 NameSTRAUMANN EMDOGAIN
Generic NameBIOLOGIC MATERIAL, DENTAL
Product CodeNQA
Date Received2015-01-09
Catalog Number075.114
Lot NumberGP625
Device Expiration Date2015-09-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIORA AB
Manufacturer AddressMALMO SW


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-01-09

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