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SEPRAMESH IP Adverse Event — Injury (MDR 1213643-2020-04032)

SEPRAMESH IP Adverse Event — Injury (MDR 1213643-2020-04032) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SEPRAMESH IP; Generic name: SURGICAL MESH; Manufacturer: DAVOL INC., SUB. C.R. BARD, INC..

DeviceSEPRAMESH IP
Generic nameSURGICAL MESH
ManufacturerDAVOL INC., SUB. C.R. BARD, INC.
Report number1213643-2020-04032
Event typeInjury
Product problemN
Date received2020-04-27
Report sourceOther, Consumer
NarrativeAT THIS TIME NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES SURGICAL INTERVENTION; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. H.11: THIS IS AN ADDENDUM TO THE INITIAL EMDR SUBMITTED (1213643-2020-04032). THIS SUPPLEMENTAL EMDR IS SUBMITTED TO REPORT THE ADDITIONAL PRODUCT AND EVENT DETAILS P
SourceopenFDA MAUDE (device adverse events)

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