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); Migration (4003)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Pain (1994); Hernia (2240); Insufficient Information (4580)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney 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 patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol mesh ¿ composix kugel (device #2).An additional emdr was submitted to represent the bard/davol mesh ¿ composix kugel (device #1).Should additional information be provided, a supplemental emdr will be submitted.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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of two unspecified composix kugel hernia patch on (b)(6)2012 and (b)(6)2020.As reported, the patient is making a claim for an adverse patient outcome against both the devices.It is alleged that the patient sustained injuries on (b)(6)2019,(b)(6)2020,(b)(6)2020,(b)(6)2020 and (b)(6)2021.Attorney 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 patient." it is also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of two unspecified composix kugel hernia patch on (b)(6) 2012 and (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against both the devices.It is alleged that the patient sustained injuries on (b)(6) 2019, (b)(6)2020 and (b)(6) 2021.Attorney 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 patient." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2012 - patient was diagnosed with ventral incisional hernia thereby underwent open repair with the implant of composix kugel mesh (device #1).Per operative notes, ¿a composix kugel mesh (device #1) was placed over the peritoneum using sutures.¿ (b)(6) 2019 - patient was diagnosed with crohn's exacerbation with perienteric abscess thereby underwent extensive lysis of adhesions.Per operative notes, ¿noted a composix kugel mesh (device #1), there were multiple adhesions were noted between the omentum and anterior abdominal wall and these were lysed.The perienteric abscess and some pus was drained.¿ (b)(6) 2020 - patient was diagnosed with loop ileostomy status and small intraabdominal abscesses thereby underwent open repair with the removal of infected mesh (device #1) and implant of phasix mesh (device #2).Per operative notes, ¿excising the old midline scar where some drainage persisted.There was some exposed mesh which seemed to be infected, and the mesh was excised (device #1).A phasix mesh (device #2) was secured on both sides of the abdomen.¿ (b)(6) 2020 - patient was diagnosed with abdominal wall abscess thereby underwent incision and drainage of abdominal wall abscess.Per operative notes, ¿able to palpate the onlay phasix mesh (device #2).The abscess was completely drained.¿ (b)(6) 2020 - patient was diagnosed with inadequately draining fistula/abscess thereby underwent repair with partial removal of unincorporated infected onlay mesh (device #2).Per operative notes, ¿identified the abscesses/drained fistula.There was some unincorporated previous phasix mesh (device #2) the portion of this mesh were excised.¿ (b)(6) 2020 - patient was diagnosed with enterocutaneous fistula with subcutaneous abscess thereby underwent abdominal wall abscess drainage and debridement.Per operative notes, ¿at the wound base of the previously placed phasix mesh (device #2) was visible.There was a segment unincorporated mesh and this was excised.Parts of the mesh that were incorporated was left in place.¿ (b)(6) 2021 - patient was diagnosed with abdominal wall abscess thereby underwent incision and abdominal wall abscess.(b)(6) 2021 - patient was diagnosed with enterocutaneous fistula with subcutaneous abscess thereby underwent wound debridement.Per operative notes, ¿there were tiny pieces of phasix mesh at the base of the wound.These were carefully excised." (b)(6) 2021 - patient was diagnosed with recurrent incisional ventral hernia; enterocutaneous fistula with small bowel and intraabdominal wall abscess cavity thereby underwent partial removal of mesh (device #2) and excision of enterocutaneous fistula, lysis of adhesions.Per operative notes, ¿there were dense adhesions with omentum and small bowel adhered to the midline abdominal wall, these was taken down.Small bowel was resected.The mesh on the right side was poorly incorporated in sections.These sections were sharply resected.The rest of the mesh on that side was well incorporated so left this in place.¿.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney 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 patient"; 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 event date, brand name, product classification code, product 510k number.Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-aug-2019) is considered to be a best estimate.This supplemental emdr represents the bard/davol phasix mesh (device #2).An additional supplemental emdr was submitted to represent the bard/davol mesh ¿ composix kugel (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.

• 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: 17000952
• Report Number: 1213643-2023-092102
• Device Sequence Number: 6649048
• Product Code: OOD
• UDI-Device Identifier: 00801741077678
• UDI-Public: (01)00801741077678(17)211028(10)HUDV0640
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: 10/28/2021
• Device Catalogue Number: 1190200
• Device Lot Number: HUDV0640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2019
• 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: Required Intervention; Disability
• Patient Age: 41 YR
• Patient Sex: Female