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

Catalog Number UNKAA089

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problems Death (1802); Injury (2348); Disability (2371)

Event Date 02/11/2017

Event Type  Death  

Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol ventrio st may have caused or contributed to the reported event. The attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided. The attorney also alleges wrongful death; no medical records, autopsy, or death certificate have been provided. 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. Device evaluated by mfr: not returned.

Event Description

Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventrio st on (b)(6) 2015. It is also alleged by patient's attorney that on (b)(6) 2017, the patient had unspecified injuries related to a defect in the ventrio st, and underwent corrective surgery. It is also alleged, by the patient's attorney that on (b)(6) 2017, patient passed away. As alleged, this short form complaint asserts a claim for wrongful death by the personal representative for the estate of the patient. As reported, the patient is making a claim for an adverse patient outcome against the ventrio st. As reported, 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. ".

• Brand Name: VENTRIO ST
• Type of Device: SURGICAL 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 ; 8015652663
• MDR Report Key: 8592767
• MDR Text Key: 144476436
• Report Number: 1213643-2019-03712
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Catalogue Number: UNKAA089
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/17/2019
• 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: 05/08/2019 Patient Sequence Number: 1