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

Catalog Number	0112960
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of two unspecified bard/davol perfix plugs on (b)(6) 2004 and (b)(6) 2008.As reported, the patient is making a claim for an adverse patient outcome against both devices.It is alleged that the patient sustained injuries on (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.
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 perfix plug (device #1).An additional emdr was submitted to represent the bard/davol perfix plug (device #2).Should additional information be provided, a supplemental emdr will be submitted.
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 perfix plug (device #1).An additional emdr was submitted to represent the bard/davol perfix plug (device #2).Addendum: this supplemental emdr is submitted to document additional information provided.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.This supplemental emdr represents the bard/davol perfix plug (device #1).An additional supplemental emdr was submitted to represent the bard/davol perfix plug (device #2).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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of two unspecified bard/davol perfix plugs on (b)(6) 2004 and (b)(6) 2008.As reported, the patient is making a claim for an adverse patient outcome against both devices.It is alleged that the patient sustained injuries on (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) 2004 - patient was diagnosed with right inguinal hernia thereby underwent open repair with implant of perfix plug (device #1) and synthetic mesh.Per op notes, ¿a direct and indirect hernia sac were identified in right inguinal region.The sacs were dissected free and excised.Indirect defect was repaired using synthetic mesh and sutured.Direct defect was repaired using perfix plug (device #1) with onlay patch and sutured.¿ (b)(6) 2008 - patient was diagnosed with left inguinal hernia thereby underwent open repair with implant of perfix plug (device #2).Per op notes, ¿an indirect hernia sac was identified, dissected and reduced.A perfix plug (device #2) with onlay patch was placed and sutured.¿ (b)(6) 2021 - patient was diagnosed with sigmoid diverticulosis, colovesical and colocutaneous fistula thereby underwent open repair with excision of perfix plug (device #2).Per op notes, ¿in left lower quadrant, the inflamed sigmoid colon was densely adherent to left pelvic side wall and prior mesh (device #2) was identified and the adhesions were taken down.The eroded prior mesh was migrated into colon.The colon was freed from mesh and colectomy was performed.The old mesh (device #2) was excised entirely.Two colocutaneous fistulas and a colovesical fistula were identified and excised.Colorectal, rectal anastomosis and ileostomy were performed.Wound vac was placed.¿.

• Brand Name: PERFIX PLUG
• 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: 14629692
• Report Number: 1213643-2022-94505
• Device Sequence Number: 6169491
• Product Code: FTL
• UDI-Device Identifier: 00801741016660
• UDI-Public: (01)00801741016660
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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 Catalogue Number: 0112960
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male