MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 PerFix Plug; Surgical Mesh

Catalog Number	0112980
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	12/27/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2005 - patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with implant of perfix plug (device 1 ¿ left and device 2 ¿ right).Per operative notes, ¿a transverse supraumbilical incision was made on both sides and carried down to the subcutaneous tissue.On the left side of the inguinal region a hernia sac was identified, which was removed.A perfix plug (device 1) was placed into the right inguinal region and secured it with sutures.Another incision was made into the right side of the inguinal region.There was a hernia sac identified.The hernia sac was dissected out.A perfix plug (device 2) was placed into the right inguinal floor and secured it with sutures.¿ on (b)(6) 2013 - patient was diagnosed with bilateral inguinal hernia, adhesion thereby underwent laparoscopic repair with implant of synthetic mesh.Per operative notes, ¿an incision was made into the inguinal region through previous incision site.There were direct inguinal hernias which were both recurrences, as previously placed perfix plug (device 1 and 2) was identified.During right-sided dissection, the perfix plug (device 2) was adhered to the peritoneum, resulting in a small peritoneal tear that was closed with clips.Both hernia sacs were taken down.A synthetic mesh was placed onto the field to cover the full defect and secured it 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.This mdr represents the perfix plug (device 2).An additional supplemental emdr was submitted to represent the 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 ; +1(800)556-6756
• MDR Report Key: 50942742
• Report Number: 1213643-2026-01259
• Device Sequence Number: 21215999
• Product Code: FTL
• UDI-Device Identifier: 00801741016684
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 0112980
• Device Lot Number: 43EOD131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/30/2026
• 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 Sex: Male
• Patient Weight: 189 LB