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

Catalog Number	0123460
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Hernia (2240); Disability (2371)
Date of Event	12/10/2008
Type of Reportable Event	Serious Injury
Additional 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, infection, hernia recurrence, hematoma and subsequent surgical intervention.The instructions-for-use supplied with the device lists hernia recurrence and hematoma as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.In regards to the infection, the instructions-for-use states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that on or about (b)(6) 2008, the patient underwent surgery for repair of a massive incisional hernia.A composix e/x, was implanted to repair the hernia defect.On or about (b)(6) 2008, the patient underwent an additional surgery.An excision of infected mesh and repair of re-recurrent incisional hernia was performed.On or about (b)(6) 2009, the patient underwent a revision of wound procedure due to a wound hematoma that released through previous incision following the patient's repair on (b)(6) 2008.On or about (b)(6) 2015, the patient underwent an additional surgery.A laparoscopic abdominal wall hernia repair with an non-bard/davol mesh was performed.On or about (b)(6) 2018, the patient underwent an additional surgery and a laparoscopic repair of incisional hernia with two non-bard/davol meshes was performed.It is alleged that the patient was injured severely and permanently.The patient suffered pain, disability, hospitalizations and additional surgeries.It is also alleged that the patient has suffered and will continue to suffer physical pain, chronic pain, mental anguish, psychological stress, depression, has undergone and will likely require medical treatments and other forms of care.Attorney also alleges that the device was defective.

• Brand Name: COMPOSIX MESH E/X
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10680968
• Report Number: 1213643-2020-09405
• Device Sequence Number: 14117366
• Product Code: FTL
• UDI-Device Identifier: 00801741031182
• UDI-Public: (01)00801741031182
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2012
• Device Catalogue Number: 0123460
• Device Lot Number: HURE2443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability