MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MODIFIED KUGEL SURGICAL MESH

Model Number 0115810

Device Problems Hole In Material (1293); Defective Device (2588); Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Pain (1994); Disability (2371)

Event Date 09/28/2015

Event Type  Injury  

Manufacturer Narrative

Addendum to the initial report. This supplemental emdr is being sent to update outcomes attributed to adv ev and the device code + description. With the current information available no conclusion can be made. If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. To date no medical records have been provided. The information provided indicates the patient experienced pain, swelling, abscess and adhesions. In regards to adhesions, adhesions are listed as a known possible adverse reaction in the instructions-for-use. The information also indicated that the mesh had a "hole" in it. A sample was not returned for evaluation therefore the allegation of a "hole" in the mesh can not be confirmed. The modified kugel is designed in such a way that there is an opening in the dual mesh. It is unclear if this designed opening is what is being referred to when talking about the hole in the mesh. With the current information available, no definitive conclusion can be made. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. Not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2006 - the patient underwent an open abdominal surgery for a ventral incisional hernia. The patient's hernia was repaired with a four inch modified kugel patch. On (b)(6) 2006 - the patient presented to the er with complaints of pain, swelling and redness of lower abdomen. The patient was allegedly found to have "an abscess. " the patient underwent an incision and drainage of the abscess in her lower abdominal wall. On (b)(6) 2015 - the patient underwent surgery to have laparoscopic repair of an incarcerated ventral hernia. The attending surgeon stated "severe adherence of bladder to old mesh and had a hole in it. " the patient was sent to recovery and discharged two days later. The attorney alleges the patient experienced adhesions, swelling, abscess and was seriously and permanently injured.

• Brand Name: MODIFIED KUGEL
• 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 6942336
• MDR Text Key: 258170023
• Report Number: 1213643-2017-00667
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030796
• UDI-Public: (01)00801741030796(17)110128(10)43AQD821
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/28/2011
• Device Model Number: 0115810
• Device Catalogue Number: 0115810
• Device Lot Number: 43AQD821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2006
• 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: 10/11/2017 Patient Sequence Number: 1