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

Catalog Number	0112950
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Seroma (2069); Hernia (2240)
Date of Event	07/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2009 - patient was diagnosed with ventral hernia thereby underwent open repair with implant of perfix plug (device 1).Per op notes, ¿a small hernia defect was noted, and the hernia was excised.A perfix plug (device 1) was placed in the hernia defect and secured with sutures.¿ on (b)(6) 2011 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent laparoscopic repair with implant of synthetic mesh.Per op notes, ¿adhesions to previous midline incision and prior mesh (device 1) were lysed.The hernia was identified and reduced.A synthetic mesh was place and tacked.¿ on (b)(6) 2014 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of ventralex st (device 2).Per op notes, ¿the hernia sac was located above the fascia and dissected from surrounding tissues.The previous placed mesh (device 1) was noted.A ventralex st (device 2) was placed and sutured.¿ on (b)(6) 2017 - patient was diagnosed with ruq abdominal pain and recurrent incisional hernia thereby underwent laparoscopic repair with excision of perfix plug (device 1) and ventralex st (device 2).Per op notes, ¿minimal adhesions were lysed.The prior meshes (device 1 and 2) were noted with chronic seroma was drained.The prior meshes (device 1 and 2) were excised.The defect was repaired primarily with sutures.¿.
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.Note, the manufacturing date (15-sep-2008) is considered to be a best estimate.This mdr represents the bard/davol perfix plug (device 1).An additional supplemental emdr was submitted to represent the bard/davol ventralex st (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.

• 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: 23897534
• Report Number: 1213643-2025-01282
• Device Sequence Number: 14734656
• Product Code: FTL
• UDI-Device Identifier: 00801741016653
• UDI-Public: (01)00801741016653(17)131028(10)HUSI2128
• 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: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: 10/28/2013
• Device Catalogue Number: 0112950
• Device Lot Number: HUSI2128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2008
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 89 KG