MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD PARASTOMAL PATCH; SURGICAL MESH

Catalog Number	0118002
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Erosion (1750); Death (1802); Inflammation (1932); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	04/08/2013
Type of Reportable Event	Death
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges wrongful death of the patient and also alleges ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the plaintiff"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix kugel hernia patch on (b)(6) 2013.As reported, the plaintiff is making a claim for an adverse patient outcome against the composix kugel hernia patch.Attorney alleges wrongful death of the patient.Attorney also alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the plaintiff." it is also alleged that the plaintiff experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix kugel hernia patch on (b)(6) 2013.As reported, the plaintiff is making a claim for an adverse patient outcome against the composix kugel hernia patch.Attorney alleges wrongful death of the patient.Attorney also alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the plaintiff." it is also alleged that the plaintiff experienced emotional distress and the device was defective.Addendum per additional information provided: on (b)(6) 2013 - patient was diagnosed with peristomal hernia thereby underwent open repair with the implant of the bard parastomal mesh.Per operative notes, ¿a bard parastomal mesh was placed and sutured.¿ on (b)(6) 2013 - patient was diagnosed with peristomal fluid collection thereby underwent placement of penrose drain.Per op notes, ¿the patient had a draining sinus tract lateral to the stoma.A penrose drain was placed deep into the tract.¿ on (b)(6) 2013 ¿ patient was diagnosed with small bowel obstruction thereby underwent open repair with explant of parastomal mesh and implant of biological mesh.Per operative notes, ¿small bowel densely adherent to the mesh from prior stomal hernia repair.The obstruction was from a proximal loop.This was dissected.There was a small abscess on the mesentery.The other two loops of bowel that were adhesed to the mesh were found to have eroded into mesh creating two enterotomies.The old mesh was removed, and a colostomy was found as the mesh had eroded into a portion of the colon.The old left lower quadrant stomal site was closed and covered with an overlay piece of biological mesh.¿ on (b)(6) 2013 - patient had history of rectal carcinoma.Patient had a large peristomal hernia and had been previously repaired.After surgery, patient developed pain, nausea, vomiting and was readmitted with small bowel obstruction.The patient was taken to operating room and performed exploratory laparotomy, small bowel resection and repair of peristomal hernia.There was a question of aspiration, which possibly turned into an aspiration pneumonia.The patient began to have signs and symptoms consistent with sepsis and developed multi organ failure requiring intubation and being placed on a ventilator.The patient withdraw life support and subsequently expired.Attorney alleged that the patient had abscess, adhesions, bowel obstructions, bowel perforations, infections, mesh migration, pain, hernia recurrence.It was also alleged that the patient had in colostomy revision, mesh erosion, enterotomies, acute and chronic inflammations foreign body giant cell reaction, multiple system organ failure secondary to sepsis.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges wrongful death of the patient and also alleges ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the plaintiff"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the product identifiers.Based on the additional information received, no conclusions can be made.Post implant of parastomal mesh, patient had small bowel obstruction, abscess, erosion, adhesions, inflammation thereby underwent repair with removal of mesh.Per discharge note, it was mentioned that ¿the patient began to have signs and symptoms consistent with sepsis and developed multi organ failure requiring intubation and being placed on a ventilator.The patient withdraw life support and subsequently expired on (b)(6) 2013.¿ there was no death certificate or autopsy report was provided.Note, the manufacturing date (15-jul-2010) is considered to be a best estimate.Updated fields: a2, b2 (outcomes attributed to adv ev, date of death), b3, b4, b5, b6, b7, d6.B (date of explant), g3, g6, h2, h4, h6, h10, h11.Corrected field: d1 (brand name), d4, g4 (pma/510(k) #).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: BARD PARASTOMAL PATCH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: 10064393
• Report Number: 1213643-2020-04847
• Device Sequence Number: 3696362
• Product Code: FTL
• UDI-Device Identifier: 00801741031113
• UDI-Public: (01)00801741031113(17)160428(10)HUUG0483
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K042026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: 04/28/2016
• Device Catalogue Number: 0118002
• Device Lot Number: HUUG0483
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Death; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male