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

Catalog Number	0112770
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Fibrosis (3167)
Date of Event	07/24/2008
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 emdr represents the bd perfix plug (device 2).An additional supplemental emdr was submitted to represent the bd perfix plug (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.
Event or Problem Description
Per information provided: on (b)(6) 2002 - patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with implant of perfix plug (device 1 and 2).(note: there is no operative notes provided for this procedure) on (b)(6) 2008 - patient was diagnosed with colovesical fistula and adhesions thereby underwent laparoscopic converted to open repair.Per op notes, ¿dense adhesions of omentum and sigmoid colon was taken down.The adhesions in both left and right lower quadrant were lysed.The colovesical fistula was noted near bladder and excised the fistula.The sigmoid colon adhesions were lysed, and a part of colon was excised.Fibrotic tissue in inguinal region was excised and sutured.¿.
Additional Manufacturer Narrative
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.Addendum h11: this is an addendum to the initial emdr submitted (mdr number: 1213643-2025-01108).It was identified that the emdr is a duplicate of a previously reported event (mdr number: 1213643-2014-00463).As such, this supplemental emdr is submitted to report the information.This supplemental emdr represents the bard/davol perfix plug (device 2).An additional supplemental emdr was submitted to represent the bard/davol perfix plug (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.
Event or Problem Description
Per information provided: (b)(6) 2002 - patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with implant of perfix plug (device 1 and 2).(note: there is no operative notes provided for this procedure) (b)(6) 2008 - patient was diagnosed with colovesical fistula and adhesions thereby underwent laparoscopic converted to open repair.Per op notes, ¿dense adhesions of omentum and sigmoid colon was taken down.The adhesions in both left and right lower quadrant were lysed.The colovesical fistula was noted near bladder and excised the fistula.The sigmoid colon adhesions were lysed, and a part of colon was excised.Fibrotic tissue in inguinal region was excised and sutured.¿.

• 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 ; 8005566756
• MDR Report Key: 23614196
• Report Number: 1213643-2025-01108
• Device Sequence Number: 8977338
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615(17)061128(10)43KLD024
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: 11/28/2006
• Device Catalogue Number: 0112770
• Device Lot Number: 43KLD024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 55 YR
• Patient Sex: Male