PRIMATRIX 607-005-440

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-06-23 for PRIMATRIX 607-005-440 manufactured by Tei Biosciences Inc..

Event Text Entries

[17210425] The pt had the device implanted during surgery on (b)(6) 2015. A pico wound vac device was also used on the wound. On (b)(6) 2015 the pt presented with large area of blanching around the wound in a circle. There was no pt discomfort, odor nor was the area tender. The would was debrided and after one week the inflammation was not visibly present. Subsequent to device removal, another collage-based wound device was placed and gave a similar type of reaction. It is probable that the pt's condition (sensitivity to collagen) caused the device to fail. The device instructions for use caution against use of the device in pts with a sensitivity to collagen.
Patient Sequence No: 1, Text Type: D, B5


[17425567] The device history record for this device was reviewed and everything was in order.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004170064-2015-00002
MDR Report Key4867745
Report Source07
Date Received2015-06-23
Date of Report2015-06-22
Date of Event2015-05-04
Date Mfgr Received2015-04-06
Device Manufacturer Date2015-02-26
Date Added to Maude2015-06-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactROBERT BUEHLER
Manufacturer Street7 ELKINS ST.
Manufacturer CityBOSTON MA 02127
Manufacturer CountryUS
Manufacturer Postal02127
Manufacturer Phone6172681616
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRIMATRIX
Generic NameWOUND COVER
Product CodeKGN
Date Received2015-06-23
Model Number607-005-440
Lot Number1501023
Device Expiration Date2019-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTEI BIOSCIENCES INC.
Manufacturer AddressBOSTON MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2015-06-23

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