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

Catalog Number 0113114

Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)

Patient Problems Nerve Damage (1979); Pain (1994); Hernia (2240); Insufficient Information (4580)

Event Date 08/07/2007

Event Type  Injury  

Manufacturer Narrative

No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, nervous system injury and pain.The instructions-for-use (ifu) supplied with the device lists hernia recurrence as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This emdr represents the bard/davol mesh ¿ composix.An additional emdr was submitted to represent the bard flat mesh.Should additional information be provided, a supplemental emdr will be submitted.

Event Description

Per implant-op notes: on (b)(6) 2006, the patient underwent a laparoscopic incisional hernia repair with a bard/davol composix mesh.On (b)(6) 2007, the patient underwent a left incisional hernia repair with a bard flat mesh.Per legal claim: attorney alleges that the patient required care and treatment prior to and on (b)(6) 2019.Attorney alleges that the patient was hurt and injured in health, strength and activity, sustaining injury to the body and shock and injury to the nervous system and person, all of which said injuries have caused and continue to cause the patient great mental, physical and nervous pain and suffering.The attorney alleges that said injuries will result in some permanent disability to the patient.It is also alleged that the device was defective.

• Brand Name: MESH ¿ COMPOSIX
• 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: 13755228
• MDR Text Key: 287118213
• Report Number: 1213643-2022-91887
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971745
• 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
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2008
• Device Catalogue Number: 0113114
• Device Lot Number: 43HND464
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2003
• 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): Required Intervention; Disability
• Patient Age: 64 YR
• Patient Sex: Female