VENTRALEX ST UNKAA086

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-05-15 for VENTRALEX ST UNKAA086 manufactured by Davol Inc., Sub. C.r. Bard, Inc..

Event Text Entries

[145161303] At this time no conclusions can be made to what extent the bard/davol ventralex st(device #1) may have caused or contributed to the reported event. The cause of the patient postoperative complications cannot be determined at this time. No lot number has been provided therefore a review of the manufacturing records is not possible at this time. Information is limited. Should additional information be provided a supplemental emdr will be submitted. This emdr represents the bard/davol ventralex st(device #1). An additional emdr was submitted to represent the bard/davol ventralex st (device #2). Not returned.
Patient Sequence No: 1, Text Type: N, H10


[145161304] Attorney alleges that the patient underwent surgery during which the patient was implanted with an unspecified bard/davol ventralex st (device #1 and device #2) on (b)(6) 2012 and (b)(6) 2014. As reported, the patient is making a claim for an adverse patient outcome against the bard/davol ventralex st (devices #1 and #2). The attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1213643-2019-03955
MDR Report Key8613342
Report SourceCONSUMER,OTHER
Date Received2019-05-15
Date of Report2019-05-15
Date Mfgr Received2019-04-24
Date Added to Maude2019-05-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJAN LING
Manufacturer Street100 CROSSINGS BLVD.
Manufacturer CityWARWICK RI 02886
Manufacturer CountryUS
Manufacturer Postal02886
Manufacturer Phone8015652663
Manufacturer G1BARD SHANNON LIMITED -3005636544
Manufacturer StreetSAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7
Manufacturer CityHUMACAO PR 00791
Manufacturer CountryUS
Manufacturer Postal Code00791
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVENTRALEX ST
Generic NameSURGICAL MESH
Product CodeFZH
Date Received2019-05-15
Model NumberNA
Catalog NumberUNKAA086
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDAVOL INC., SUB. C.R. BARD, INC.
Manufacturer Address100 CROSSINGS BLVD. WARWICK RI 02886 US 02886


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-05-15

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