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

Catalog Number UNKAA016

Device Problems Fracture (1260); Nonstandard Device (1420); Difficult to Remove (1528); Sticking (1597); Malposition of Device (2616); Folded (2630)

Patient Problems Abdominal Pain (1685); Anemia (1706); Hernia (2240); Blood Loss (2597)

Event Date 08/13/2012

Event Type  Injury  

Event Description

The following was reported to davol by the pt's atty: on (b)(6) 2004, the pt underwent an incisional hernia repair with implant of a composix kugel hernia patch.On (b)(6) 2012, the pt presented to the physician with complaints of ongoing and increasing severe abdominal pain.Int is alleged, that the pt had a recurrent hernia with palpable mesh at the hernia site.On (b)(6) 2012, the pt underwent abdominal wall reconstruction.It is alleged that the physician noted in his findings that the composix kugel hernia patch had folded and buckled with the ptfe folded under exposing the polypropylene to the bowel.The small bowel was densely adherent to the mesh in several locations where this buckle had occurred and this was also the cause of the reherniation.To facilitate mesh extraction, the physician divided the mesh in the midline which exposed the memory recoil ring of the mesh.It was observed at this time that the ring had allegedly previously fractured approximate to the buckle location, and was lodged in the mesh material.Post removal of the mesh, the pt allegedly suffered acute blood loss anemia and hemodynamic instability resulting in emergent return to surgery.

Manufacturer Narrative

The pt's atty did not provide medical records.Without a lot number, a review of the manufacturing records could not be conducted.Additionally, no product was returned for eval.With the currently available info, no conclusion can be drawn.We have requested add'l info.If add'l event and/or eval info is obtained, a f/u mdr will be submitted.Product id not provided at this time.Reported as extra large composix kugel mesh correction/removal numbers listed for extra large sizes.Z-0524-06, z-0525-06, z0526-06, z0762-06.

• Brand Name: MESH - COMPOSIX KUGEL
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; warwick RI
• Manufacturer (Section G): BARD SHANNON LTD; lot # 1, rd # 3, km 79.7; san geronimo industrial park; humacao PR 00791
• Manufacturer Contact: steven figueroa ; 100 crossings blvd; warwick, RI 02886 ; 8005566756
• MDR Report Key: 4036827
• MDR Text Key: 4879557
• Report Number: 1213643-2014-00279
• 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: Other
• Reporter Occupation: Attorney
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2014
• Initial Date FDA Received: 08/20/2014
• 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: SEE SEC. H10 FOR INFO.
• Patient Sequence Number: 1
• Patient Outcome(s): Disability