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

Model Number 0123810

Device Problems Defective Device (2588); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Pain (1994); Disability (2371); Obstruction/Occlusion (2422)

Event Date 11/19/2014

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.Based on the information provided, it is alleged the patient underwent an additional surgery to repair a bowel obstruction.At this time it is unclear if the bowel obstruction was related to the implanted composix ex mesh.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2005 - the patient underwent surgery for repair of a ventral hernia, a composix e/x hernia patch was implanted to repair the hernia defect.(b)(6) 2014 - the patient underwent an additional surgery to repair a bowel obstruction.The patient has suffered and will continue to suffer pain and was injured severely and permanently.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2005 - the patient underwent surgery for repair of a ventral hernia, a composix e/x hernia patch was implanted to repair the hernia defect.(b)(6) 2014 - the patient underwent an additional surgery to repair a bowel obstruction.The patient has suffered and will continue to suffer pain and was injured severely and permanently.Addendum per additional information provided: (b)(6) 2005 - patient was diagnosed with large ventral hernia thereby underwent laparoscopic repair with implant of composix ex mesh.Per operative notes, ¿part of the umbilicus had a lot of fatty tissue that needed to be excised and removed.Once this was cleared up, we were then able to measure the hernia.Composix e/x mesh was passed into the abdomen and it was placed on one end and then the other end of the mesh longitudinally to position it correctly in the center of the hernia and tacked.¿ (b)(6) 2014 - patient was diagnosed with bowel obstruction and pain thereby underwent open exploratory laparotomy.Per operative notes, ¿mesh was identified and it was cut in the middle and going to the belly.Large amount of proximal jejunum was identified to be very dilated, identified the point of obstruction and area of multiple adhesions in the terminal jejunum which were lysed, this looked like a tube of toothpaste causing the obstruction.The obstruction was then released.¿ attorney alleges that the patient had adhesions, bowel obstructions and pain.

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.Based on the information provided, it is alleged the patient underwent an additional surgery to repair a bowel obstruction.At this time it is unclear if the bowel obstruction was related to the implanted composix ex mesh.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 8 years implant of composix mesh e/x, patient had adhesions, bowel obstructions and pain thereby underwent repair.The instruction for use (ifu) supplied with device list adhesions as a possible complication.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.H3 other text : not returned.

• Brand Name: COMPOSIX MESH E/X
• 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: 7140229
• MDR Text Key: 95589197
• Report Number: 1213643-2017-01089
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031212
• UDI-Public: (01)00801741031212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002684
• 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: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2008
• Device Model Number: 0123810
• Device Catalogue Number: 0123810
• Device Lot Number: 43FND338
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2003
• 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): Disability; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male