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BARD FLAT MESH Adverse Event — Injury (MDR 1213643-2020-04148)

BARD FLAT MESH Adverse Event — Injury (MDR 1213643-2020-04148) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BARD FLAT MESH; Generic name: SURGICAL MESH; Manufacturer: DAVOL INC., SUB. C.R. BARD, INC..

DeviceBARD FLAT MESH
Generic nameSURGICAL MESH
ManufacturerDAVOL INC., SUB. C.R. BARD, INC.
Report number1213643-2020-04148
Event typeInjury
Product problemN
Date received2020-04-28
Report sourceCONSUMER, OTHER
NarrativeAT THIS TIME NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES ADVERSE PATIENT OUTCOMES AGAINST THE HERNIA MESH DEVICE; HOWEVER, SPECIFIC DETAILS HAVE NOT BEEN PROVIDED. REVIEW OF THE ADVERSE REACTION SECTION OF THE IFU LISTS ADHESIONS, HERNIA RECURRENCE AND INFLAMMATION AS POSSIBLE COMPLICATIONS. IN REGARDS TO THE ALLEGED INFECTION, THE WARNING SECTION OF THE IFU STATES "IF AN INFECTION
SourceopenFDA MAUDE (device adverse events)

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