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

Catalog Number 0010206

Device Problems Break (1069); Defective Device (2588); Folded (2630); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Fistula (1862); Pain (1994); Disability (2371); Bowel Perforation (2668)

Event Date 09/05/2014

Event Type  Injury  

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 alleges the patient experienced a ring break.Without the sample being returned for evaluation, the allegation of a ring break can not be assessed and the possible reason for the break could not be determined.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.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 to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2006 - the patient underwent a hernia repair with implant of a composix kugel mesh device.It is alleged the recoil ring in the composix kugel product subsequently broke and caused the device to flip over and perforate patient's bowel.The patient required substantial additional medical procedures and care to remove the defective composix kugel product, repair her bowel and to treat other resulting complications.The attorney alleges the patient experienced pain, additional surgical procedure, ring break, bowel perforation and was seriously and permanently injured.

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 alleges the patient experienced a ring break.Without the sample being returned for evaluation, the allegation of a ring break can not be assessed and the possible reason for the break could not be determined.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.Addendum: h11: this supplemental mdr is submitted to document additional information provided and to correct the manufacturing date.Based on the available information, no conclusion can be made.Per the medical record review, post implant of composix kugel mesh, patient developed fistula, abscess, adhesions and underwent removal of the mesh.Per the op-notes, ¿the mesh was flipped over and was all broken in several pieces and also eroded in the small bowel¿.The instructions-for-use supplied with the device list adhesions and fistula formation as possible complications.Review of manufacturing records confirms product was manufactured to specification.Updated fields: a2, b3 (date of event), b4, b5, b6, b7, d6b (date of explant), e3, g1, g3, g6, h2, h3, h6, h10, h11.Corrected field: h4 (manufacturing date) note: section a through f - the information provided by bd 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 bd.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2006 - the patient underwent a hernia repair with implant of a composix kugel mesh device.It is alleged the recoil ring in the composix kugel product subsequently broke and caused the device to flip over and perforate patient's bowel.The patient required substantial additional medical procedures and care to remove the defective composix kugel product, repair her bowel and to treat other resulting complications.The attorney alleges the patient experienced pain, additional surgical procedure, ring break, bowel perforation and was seriously and permanently injured.Addendum per additional information provided: on (b)(6) 2006 - patient was diagnosed with incarcerated ventral incisional hernia and underwent exploratory laparotomy with the implant of composix kugel mesh.Per operative notes ¿the size of the defect was properly measured and composix kugel mesh was secured".(note: no product identifiers were provided for the old mesh) on (b)(6) 2014 - patient was diagnosed with small bowel fistula and underwent removal of the mesh.Per operative notes ¿we then entered the mesh and immediately found multiple abscesses.Extensive adhesiolysis were performed and the mesh and fistula tract was taken out.The mesh was basically flipped over, was all broken in several pieces and also eroded in the small bowel¿.Attorney alleges that the patient had abscess, adhesions, bowel obstruction, bowel perforation, bowel removal, fistula, infection, hernia recurrence, ring break, mesh excision, necrotic tissue, pain, emotional injuries and wound vac placement.

• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 7007438
• MDR Text Key: 91290359
• Report Number: 1213643-2017-00804
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

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 Expiration Date: 04/28/2011
• Device Catalogue Number: 0010206
• Device Lot Number: 43DQD802
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 06/05/2023
• Supplement Dates FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2006
• 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): Life Threatening; Disability; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female