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

Catalog Number	0112780
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	06/24/2005
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2005- patient was diagnosed with right scrotal hernia, left inguinal hernia, direct and umbilical hernia, thereby underwent open repair with implant of perfix plugs (device 1 and 2).Per op notes, ¿in the right inguinal region, large hernia sac with omentum was identified and reduced.An extra-large perfix plug (device 1) was placed in the right inguinal region and sutured.Corresponding mesh was placed in the floor of the canal and sutured.Then in left inguinal region, hernia was identified and reduced.A perfix plug (device 2) was placed underneath the cord structure and sutured¿.On (b)(6) 2005- patient was diagnosed with left inguinal hernia, thereby underwent open repair with explant of perfix plug (device 2) and implant of synthetic mesh.Per op notes, ¿in the lower abdomen and left groin region, the previously place perfix plug (device 2) was removed, where a large direct sac in the floor of the canal was identified and reduced.A synthetic mesh was placed and sutured.On (b)(6) 2011- patient was diagnosed with bilateral inguinal hernias with right scrotal pain, thereby underwent laparoscopic repair converted to open repair with partial explant of perfix plug and implant of bard soft mesh (device 3).Per op notes, ¿omentum herniate through the right inguinal defect was identified.Significant amount of omentum along with chronic scarring was identified and reduced.The hernia sac was found to be adherent and was carefully dissected off the perfix plug (device 1), with that portion of the plug subsequently removed.Adhesiolysis was performed.A 3×6 cm bard soft mesh (device 3) was placed into the preperitoneal space of the abdominal region and secured.¿.
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.

• 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: 23474564
• Report Number: 1213643-2025-01065
• Device Sequence Number: 10229072
• Product Code: FTL
• UDI-Device Identifier: 00801741016622
• UDI-Public: (01)00801741016622(10)43APD471
• 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: 2005
• Device Explanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2025

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: 0112780
• Device Lot Number: 43APD471
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/05/2025
• 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: 58 YR
• Patient Sex: Male