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MESH - VENTRALEX Adverse Event — Injury (MDR 1213643-2020-03993)

MESH - VENTRALEX Adverse Event — Injury (MDR 1213643-2020-03993) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MESH - VENTRALEX; Generic name: SURGICAL MESH; Manufacturer: DAVOL INC., SUB. C.R. BARD, INC..

DeviceMESH - VENTRALEX
Generic nameSURGICAL MESH
ManufacturerDAVOL INC., SUB. C.R. BARD, INC.
Report number1213643-2020-03993
Event typeInjury
Product problemN
Date received2020-04-27
Report sourceCONSUMER, OTHER
NarrativeAT THIS TIME NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. THIS EMDR REPRESENTS THE BARD/DAVOL VENTRALEX HERNIA PATCH (DEVICE #2). ADDITIONAL EMDRS WERE SUBMITTED TO REPRESENT THE BARD/DAVOL CO
SourceopenFDA MAUDE (device adverse events)

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