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

Catalog Number	1190200
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Fistula (1862); Hematoma (1884); Necrosis (1971); Sepsis (2067); Drug Resistant Bacterial Infection (4553)
Date of Event	02/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided by patient's attorney: on (b)(6) 2010 - patient was diagnosed with small bowel obstruction secondary to incarcerated umbilical hernia thereby underwent open repair with the implant of composix e/x mesh (device #1).Per operative notes, "the hernia sac was dissected free back to fascia.The sac was very thick walled of the fat in the preperitoneal space.The bowel was then reduced.A composix e/x mesh (device #1) was placed in the intraperitoneal space with ptfe side toward bowel and sutured.Then the defect was closed over this mesh." on (b)(6) 2016 - patient visited hospital for abdominal wall cellulitis thereby provided with medication.On (b)(6) 2017 - patient was diagnosed with enterocutaneous fistula and ventral hernia thereby underwent robotic assisted laparoscopic repair with explant of composix e/x mesh (device #1), implant of phasix mesh (device #2) and drainage of intraabdominal abscess.Per operative notes, "the area of fistula in the mid abdomen with large amount of adhesions were noted.The mesh was adhesed to the bowel with large opening consistent with area of fistula, underneath of the mesh large pocket of abscess and pus noted which was debrided.This area of small bowel was resected.A piece of phasix mesh (device #2) was used to repair the hernia and sutured in place." on (b)(6) 2017 - patient underwent needle enterostomy to drain the fluid collection.On (b)(6) 2017 - patient was diagnosed with intra-abdominal infection, cellulitis of right lower extremity and enterocutaneous fistula thereby underwent wound care.On (b)(6) 2017 - patient was admitted for sepsis, found to have mrsa bacteremia, new right lower quadrant enterocutaneous fistula developed at old enterocutaneous fistula site and left upper quadrant hematoma developed into a subcutaneous abscess with pus thereby underwent treatment.On (b)(6) 2017 - patient was diagnosed with left abdominal wall abscess thereby underwent debridement.On (b)(6) 2017 - patient had multiple follow-up visits for enterocutaneous fistula.On (b)(6) 2017 - patient visited hospital for preoperative assessment.On (b)(60 2017 - patient underwent laparotomy/closure of fistula.(note, per product identifiers provided two non-bd meshes were implanted whereas no op notes provided).Attorney alleged that the patient had abscess, fistulae, infection, mesh migration, pain, abdominal wall cellulitis and emotional injuries.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, post implant of phasix mesh, patient was diagnosed with sepsis, fistula, infection, abscess, hematoma and necrosis thereby underwent medical/surgical intervention.The instructions-for-use supplied with the device lists fistula, infection and hematoma as possible complications.Regarding infection the warnings section states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the mesh." review of manufacturing records confirms product was manufactured to specification.Note, the manufacturing date (15-aug-2016) is considered to be a best estimate.This emdr represents the phasix mesh (device #2).An additional supplemental emdr was submitted to represent the composix mesh ex (device #1).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: PHASIX MESH
• Common Device Name: 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: 21252813
• Report Number: 1213643-2025-090040
• Device Sequence Number: 18411395
• Product Code: OOD
• UDI-Device Identifier: 00801741077678
• UDI-Public: (01)00801741077678(17)180828(10)HUAV0565
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2025

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: 08/28/2018
• Device Catalogue Number: 1190200
• Device Lot Number: HUAV0565
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2016
• 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: Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 106 KG