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 Codes	Scar Tissue (2060); Hernia (2240)
Date of Event	07/17/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2011, patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with implant of four perfix plugs (device 1, 2,3 and 4).Per operative notes, "in the left groin, a direct and indirect inguinal hernia was noted.The transversalis fascia of the direct hernia was excised and a large perfix plug (device 1) was placed and closed with sutures.The indirect hernia was separated from the cord structures and reduced back into abdomen.A small perfix plug (device 2) was placed over the floor of the inguinal canal and approximated with sutures.In the right groin, a large direct hernia as well as indirect hernia was noted.The direct hernia was reduced, extra-large perfix plug (device 3) was placed and external oblique was closed over the plug with sutures.To the indirect hernia, the sac was reduced and another small perfix plug (device 4) was placed and secured with sutures." on (b)(6) 2012, patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with removal of small perfix plug (device 4) and implant of perfix plug (device 5).Per operative notes, "through the prior scar in the right groin, the mesh (device 3) was seen and left situ.The previously placed small perfix plug mesh (device 4) with recurrent inguinal hernia was noted.The small perfix plug mesh (device 4) was removed and dissected away.The sac was separated from the cord structures and another large perfix plug (device 5) was placed in the inguinal floor.The fascia was closed and reapproximated 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-apr-2010) is considered to be a best estimate.This emdr represents the perfix plug (device 3).Additional supplemental emdrs were submitted to represent perfix plug (device 4 & 5).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: 24829658
• Report Number: 1213643-2026-00455
• Device Sequence Number: 13067015
• Product Code: FTL
• UDI-Device Identifier: 00801741016622
• UDI-Public: (01)00801741016622(17)150528(10)HUUD1772
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2015
• Device Catalogue Number: 0112780
• Device Lot Number: HUUD1772
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2010
• 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