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Adverse Event Report

DAVOL INC. SUBSIDIARY OF C.R. BARD, INC. KUGEL MESH   back to search results
Event Description

Recently a pt was hospitalized with groin pain and underwent a right inguinal herniorrhaphy utilizing kugel mesh. The pt had been afebrile up until the time of operation. Post operatively, the pt began having fevers very soon after the completion of surgery. The pt was found to have necrotizing fasciitis and underwent several debridements. This pt was then transferred to a facility with hyperbaric oxygen capabilities. The hernia repair was routine and there was no break in sterile technique.

 
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Brand NameKUGEL MESH
Type of DeviceMESH
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
DAVOL INC. SUBSIDIARY OF C.R. BARD, INC.
100 sockanossett cross rd.
cranston RI 02920
Device Event Key304560
MDR Report Key314921
Event Key296048
Report NumberMW1020992
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Report Date 01/15/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/02/2001
Is This An Adverse Event Report? No
Device Operator Health Professional
OTHER Device ID NumberNI
Is the Device an Implant? Yes

Database last updated on January 30, 2009

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