COTTON WEDGE BONE GRAFT 5MM PRODUCT CODE PCOT-181405 03-1001174

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for COTTON WEDGE BONE GRAFT 5MM PRODUCT CODE PCOT-181405 03-1001174 manufactured by Paragon 28.

Event Text Entries

[144394810] Here are the quick bullet points of my case: i was a (b)(6) y/o female with no major health issues and not diabetic that resides in the (b)(6) area. Went walking and my left foot hurt after a few miles. Went to the dr, found out my left arch collapsed. Did conservative therapies for 3 months (steroids, ibuprofen, injections) ended up needing surgery on (b)(6) 2015; developed post operative infection 7 days later. Oral antibiotics did not work; went to hosp for iv antibiotics. Determined it was mycobacteria fortuitum 28 days into the infection. Spent next four months fighting the infection. Had ten surgeries to fight the infection along with antibiotics. Could not win the battle. Had to amputate leg below the knee. Had the specialists in mycobacterium ((b)(6)) determine the bone graft used in the surgery was contaminated with mycobacterium fortuitum (b)(6). May have also been from a warming blanket getting it off the floor during the procedure but unlikely. No medical malpractice found by the drs. No idea about the surgical center however. Do they sterilize their equipment appropriately? Did someone not wash their hands? I kept a blog that starts in (b)(6) 2015 over the entire issue. (b)(6); now disabled permanently due to the after amputation issues. Saved the bone graft used from the initial surgery and sent to (b)(6) science center at (b)(6) to test for the mycobacterium (b)(6). They were able to confirm it was contaminated, including bone graft form and the company (b)(6) and their order of the cotton wedge bone graft that was used. I have a picture of the product. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086387
MDR Report Key8582542
Date Received2019-05-03
Date of Report2019-05-01
Date of Event2015-06-30
Date Added to Maude2019-05-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCOTTON WEDGE BONE GRAFT 5MM
Generic NameBONE WEDGE
Product CodePLF
Date Received2019-05-03
Model NumberPRODUCT CODE PCOT-181405
Catalog Number03-1001174
Lot NumberDONOR#40742
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerPARAGON 28


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-05-03

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