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

Catalog Number 0010204

Device Problems Defective Device (2588); Material Deformation (2976)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient. The sample was not returned for evaluation. Based on the limited information provided at this time, no conclusions can be made. Inflammation is identified in the adverse reaction section of the instructions-for-use as a possible complication. No lot number was provided therefore a review of the manufacturing records is not possible at this time. Based on the date of implant the subject product is part of the composix kugel recall initiated on (b)(4) 2005. Should additional information be provided a supplemental emdr will be submitted. 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. Not returned.

Event Description

The following was alleged by the patient's attorney:on (b)(6) 2006: the patient underwent a hernia surgery for a ventral hernia and umbilical hernia. As reported, the patient's hernia was repaired with a bard/davol 11. 4cm x 11. 4cm oval kugel patch, product code 0010204. It is alleged that sometime after placement the device malfunctioned by, inter alia, contracting, suffering degradation, and causing an intense foreign body and inflammatory response. It is alleged that as a result of these failures, the patient has suffered severe injuries, required substantial medical care, has suffered and will continue to suffer physical pain.

• 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: francesca santamaria ; 100 crossings blvd.; warwick, RI 02886 ; 4018258538
• MDR Report Key: 7155276
• MDR Text Key: 96109976
• Report Number: 1213643-2017-01148
• 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: consumer,other
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/29/2017

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 Catalogue Number: 0010204
• 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: 12/12/2017
• 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
• Removal/Correction Number: Z-0761-06

Patient Treatment Data

Date Received: 12/29/2017 Patient Sequence Number: 1