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

Catalog Number	0112750
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	08/22/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2008 - patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with implant of perfix plug (device 1 and 2).Per op notes, ¿a left groin incision was made.The inguinal canal was dissected out.The indirect sac was also excised.A small indirect defect was noted.A perfix plug (device 1) was placed and secured with suture.The floor of the canal was reconstructed with mesh sewn to the pubic tubercle.Similar repair was performed to the right groin.A small indirect sac was identified and excised.A perfix plug (device 2) was placed and the floor was reconstructed with the same mesh and secured with suture.¿ (b)(6) 2012 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with partial excision of perfix plug (device 2) and implant of synthetic mesh and bard mesh pre-shaped (device 3).Per op notes, ¿an incision was made through the old scar.The old mesh was fused to the underside of the external oblique and was freed up.The prior mesh (device 2) was noted in the direct area.An obvious direct hernia defect was noted on palpation.The perfix plug (device 2) was partially resected.The mesh that was sutured cephalad was intact.The defect was inferior medially.The defect was defined.A synthetic mesh was placed in the area of the defect.An onlay patch repair was performed using bard mesh pre-shaped (device 3) which was placed and secured on top of the pubic tubercle with sutures.Inferiorly the mesh was sutured to cooper¿s ligament and superiorly sutured to the intact mesh underlying the new mesh under the old mesh.¿ (b)(6) 2012 ¿ patient was diagnosed with bilateral recurrent inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax light mesh (device 4 and 5).Per op notes, ¿an infraumbilical incision was made and carried to the fascia.The right anterior rectus fascia was incised.The hernia sac was identified and dissected away from the abdominal wall.A piece of 3dmax light mesh (device 4) was placed on right inguinal region and secured into place with tacker.A piece of 3dmax light mesh (device 5) was placed on the left inguinal region and the peritoneal defects were closed with suture.¿.
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 1).Additional supplemental emdrs were submitted to represent the perfix plug (device 2) and bard mesh pre-shaped (device 3).Note, the manufacturing date (15-mar-2008) is considered to be a best estimate.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: 50458144
• Report Number: 1213643-2026-01111
• Device Sequence Number: 9898023
• Product Code: FTL
• UDI-Device Identifier: 00801741016592
• UDI-Public: (01)00801741016592(17)130328(10)HUSC0838
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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 Expiration Date: 03/28/2013
• Device Catalogue Number: 0112750
• Device Lot Number: HUSC0838
• 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: 08/18/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2008
• 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 Sex: Female