MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP; SURGICAL MESH

Catalog Number UNKAA066

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

Patient Problems Hernia (2240); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

The complainant has indicated that no additional information would be provided at this time.Based on the information available, no conclusions can be made.A lot number was not provided, therefore a review of the manufacturing records could not be conducted.Recurrence is identified in the adverse reaction section of the ifu as a possible complication.If additional information is obtained, a supplemental mdr will be submitted.This mdr represents the sepramesh reported to have been implanted in 2011.A separate mdr was sent to document the bard mesh reported to have been implanted in 2009.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Device remains implanted.

Event Description

It has been reported that in 2009 the patient underwent abdominal hernia repair and was implanted with a bard mesh device.As reported the hernia recurred and in 2011 the patient twice underwent emergency surgery and was implanted with a bard sepramesh.Following the surgery in 2011 it is reported that the patient experienced complications of bleeding in which a drain had to be placed, numbness of the leg (unspecified side), hernia recurrence and most recently in 2016 a bowel obstruction and hospitalization.

Event Description

It has been reported that in 2009 the patient underwent abdominal hernia repair and was implanted with a bard mesh device.As reported the hernia recurred and in 2011 the patient twice underwent emergency surgery and was implanted with a bard sepramesh.Following the surgery in 2011 it is reported that the patient experienced complications of bleeding in which a drain had to be placed, numbness of the leg (unspecified side), hernia recurrence and most recently in 2016 a bowel obstruction and hospitalization.Addendum to include original complaint, as well as, additional information provided by the patients attorney: (b)(6) 2009: the patient underwent abdominal hernia repair and was implanted with a bard/davol composix l/p(device #1) mesh device.(b)(6) 2011:the patient twice underwent emergency surgery and was implanted with a bard/davol sepramesh ip(device #2).Following the surgery in 2011 it is reported that the patient experienced complications of bleeding in which a drain had to be placed, numbness of the leg (unspecified side), hernia recurrence.2016: the patient had a bowel obstruction and hospitalization.

Manufacturer Narrative

This is an addendum to the initial mdr to document additional information provided by the patient's attorney.The additional information provided by the attorney identified the previously ¿unspecified bard/davol mesh¿ as a bard/davol composix l/p(device #1) of (b)(6) 2009, and the implantation date of (b)(6) 2011 for the sepramesh ip(device #2).As previously reported, there is no connection that can be made at this time between the reported unspecified post-operative complications and the bard/davol device used to treat the patient.The patient's attorney alleges unspecified injuries on the date of implant; however, no details have been provided regarding the nature of the injury.The attorney did not allege any specific device failure and no medical records have not been provided.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.This emdr represents the bard/davol sepramesh ip (device #2) an additional emdr was submitted to represent the bard/davol composix l/p (device #1).Should additional information be provided, a supplemental emdr will be submitted.Remains implanted.

• Brand Name: SEPRAMESH IP
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6234259
• MDR Text Key: 64238280
• Report Number: 1213643-2017-00015
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K063739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability