LEECHES USA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-16 for LEECHES USA manufactured by Leeches Usa.

Event Text Entries

[22110132] Pt had a traumatic finger amputation on (b)(6) 2012 and surgical reimplantation was attempted along with use of leech therapy from (b)(6) 2012. Ertapenem given as prophylaxis during this time. The reimplantation was not successful and the digits were subsequently removed via surgical amputation. Soft tissue coverage was provided with a radial forearm flap and split thickness skin grafting. On (b)(6) 2012,the skin graft appeared infected. Cultures of the tissue were done on (b)(6) 2012 and grew aeromonas resistant to ertapenem and fluoroquinolones. The pt required 3 surgical irrigation/debridement procedure, hyperbaric oxygen therapy and 19 days of iv antibiotics including home infusion therapy. The infectious disease attending and i would be happy to have a phone discussion about this if desired. I have attempted to discuss with (b)(6) to see if they had other reports of this but they gave incorrect info, and clearly had no medical or antibiotic knowledge. We plan to discuss with (b)(4) early next week - they are the suppliers and i believe are the ones with the fda approval. As an aside, there was incorrect info in the (b)(6) package insert, which is part of the reason they were giving misinformation. It said the quinolones and tmp/smx were 3rd generation cephalosporins. The lady on the phone kept saying we caused the infection because we did not give a 3rd gen cephalosporin. Our micro lab has retained the specimen from the (b)(6) as well.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5025082
MDR Report Key2541462
Date Received2012-04-16
Date of Report2012-04-12
Date of Event2012-03-08
Date Added to Maude2012-04-20
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLEECHES USA
Generic NameLEECHES
Product CodeNRN
Date Received2012-04-16
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerLEECHES USA


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2012-04-16

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