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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST SURGICAL MESH Back to Search Results
Catalog Number UNKAA078
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Death (1802); Injury (2348)
Event Type  Death  
Manufacturer Narrative
At this time no conclusions can be made. The attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided. The cause of the patient postoperative complications cannot be determined at this time. No medical records, autopsy, or death certificate have been provided. No lot number has been provided therefore a review of the manufacturing records is not possible at this time. Should additional information be provided a supplemental emdr will be submitted. Not returned.
 
Event Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventralight st on (b)(6) 2017. It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s). As reported, the patient is making a claim for an adverse patient outcome against the bard/ davol ventralight st. As reported, the attorney alleges patient experienced emotional distress, the device was defective and wrongful death.
 
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Brand NameVENTRALIGHT ST
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
BARD SHANNON LIMITED 3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
jan ling
100 crossings blvd.
warwick, RI 02886
8015652300
MDR Report Key9466851
MDR Text Key170688272
Report Number1213643-2019-12123
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberUNKAA078
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/13/2019 Patient Sequence Number: 1
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