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

Catalog Number UNKAA016

Device Problems Defective Device (2588); Material Protrusion/Extrusion (2979)

Patient Problems Pain (1994); Injury (2348); Disability (2371)

Event Date 06/23/2017

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.The attorney alleges, "patient underwent an additional surgery to remove mesh protruding from her abdominal wall" no medical records have been provided related to the surgery or alleged adverse outcome.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.Not returned.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2006: the patient underwent surgery for implant of an unspecified bard/davol composix kugelpatch.(b)(6) 2017: the patient underwent an additional surgery to remove mesh protruding from her abdominal wall.The patient is only making a claim for an adverse patient outcome against the composix kugel hernia patch.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: 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: jan ling ; 100 crossings blvd.; warwick, RI 02886 ; 8015652663
• MDR Report Key: 8092080
• MDR Text Key: 128020608
• Report Number: 1213643-2018-04110
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003323
• 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: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability