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

Catalog Number 0010205

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Pain (1994)

Event Date 02/02/2006

Event Type  Injury  

Manufacturer Narrative

This is an addendum to the initial emdr to document additional information provided. As reported the surgeon has not assessed the reported pain as being related to the implanted devices. At this time the patient's treatment is ongoing. Based on the additional information provided, the results of this investigation remain unchanged, at this time we are unable to determine to what extent, if any the bard devices may have caused or contributed to the events as alleged. Should additional information be provided, a supplemental emdr will be submitted. This supplemental emdr represents lot number 43dpd334 (device#1) an additional supplemental emdr was submitted representing lot number 43bod272 (device #2).

Event Description

It was reported that approximately ten years ago (no date provided) the patient was implanted with two bard composix kugel hernia patch devices. The patient has recently presented to his physician alleging the devices are causing him "abdominal pain and problems" and wants to have the devices removed. Addendum: on (b)(6) 2005 - the patient was implanted with a bard composix kugel hernia patch (device #1) to treat the hernia defect. On (b)(6) 2006 - the patient underwent an additional surgery in which a bard composix kugel hernia patch (device #2) was placed at the edge of the prior implant to reinforce the area. As reported the implanting surgeon believes the patient may have undergone a primary repair of the defect prior to the implant of the composix kugel hernia patch devices. The allegation of pain is a recent complication and the surgeon has not assessed it to be related to the earlier repairs. The surgeon has refered the patient to a gi specialist for additional consideration of cause of the pain.

Manufacturer Narrative

Based on the limited information provided we are unable to determine to what extent, if any the bard devices may have caused or contributed to the events as alleged. To date no additional information has been provided. There have been no other reported complaints for this lot number. Should additional information be provided, a supplemental emdr will be submitted. This emdr represents lot number 43dpd334 (device#1) an additional emdr was submitted representing lot number 43bod272 (device #2) not returned.

Event Description

It was reported that approximately ten years ago (no date provided) the patient was implanted with two bard composix kugel hernia patch devices. The patient has recently presented to his physician alleging the devices are causing him "abdominal pain and problems" and wants to have the devices removed.

• Brand Name: MESH - COMPOSIX 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7155240
• MDR Text Key: 255166419
• Report Number: 1213643-2017-01145
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K003323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/28/2010
• Device Catalogue Number: 0010205
• Device Lot Number: 43DPD334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2005
• 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: 12/29/2017 Patient Sequence Number: 1