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

Model Number	0112700
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Adhesion(s) (1695); Sepsis (2067); Bowel Perforation (2668)
Date of Event	07/10/1999
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event.Based on a review of medical records, the patient experienced perforation, adhesions, pain and sepsis.Adhesions is a known inherent rick of surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.In regards sepsis/infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ without a lot number a review of the manufacturing records could not be conducted.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 or Problem Description
The following is based on a review of medical records provided to davol by the patient's attorney: (b)(6) 1997 - the patient was diagnosed with vaginal vault prolapse, enterocele and symptomatic pelvic relaxation.The patient underwent an abdominal sacrocolpopexy with implant of a bard pre-shaped mesh.(b)(6) 1999 - (b)(6) 1999 - the patient presented to the hospital with complaints of abdominal pain and chronic constipation.The patient was admitted to the intensive care unit with a primary diagnosis of perforation of her bowel and a secondary diagnosis of sepsis with right groin embolism.(b)(6) 1999 - the patient was diagnosed with perforated sigmoid colon secondary to stercoral colitis.The patient underwent a two part procedure which included a small bowel resection and colostomy formation with explant of the bard pre-shaped mesh and removal of a right groin embolism.Per operative details and findings "the small bowel appeared to be adherent to a piece of mesh (davol) which appeared to be secondary to a prior surgery.She had lots of adhesions between the intestine and the mesh.The small bowel was removed from the mesh, and the small bowel was able to be eviscerated.There was a large hole in the anterior wall of the sigmoid colon, through which the feces appeared to be emanating.Attention was then directed into the pelvis and the piece of mesh that appeared to rise out of the retroperitoneum, was transected flush with the sacrum using scissors." the patient remained in the critical care unit for several weeks due to sepsis from the fecal contamination.(b)(6) 2000 - the patient underwent a colonoscopy with findings of diverticulosis and colon polyps.(b)(6) 2000 - the patient underwent closure of her colostomy with a bowel resection.

• Brand Name: PRE-SHAPED MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7150796
• Report Number: 1213643-2017-01118
• Device Sequence Number: 16377081
• Product Code: FTL
• UDI-Device Identifier: 00801741016547
• UDI-Public: (01)00801741016547
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1997
• Device Explanted Year: 1999
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 12/28/2017

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 Model Number: 0112700
• Device Catalogue Number: 0112700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 12/28/2017
• 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; Life Threatening; Required Intervention; Disability
• Patient Age: 64 YR