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

Catalog Number	0112760
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	01/10/2013
Type of Reportable Event	Serious Injury
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-jan-2008) is considered to be a best estimate.This emdr represents the bard perfix plug (device 2).An additional supplemental emdr was submitted to represent the bard 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.
Event or Problem Description
Per information provided: on (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, "an incision was made in the right inguinal region.An indirect hernia sac was identified and reduced.A perfix plug (device 1) was placed into the defect and secured with suture.A large patch was then secured to the pubic tubercle with suture.The left inguinal hernia was repaired with a perfix plug (device 2) and secured with suture." on (b)(6) 2013 - patient was diagnosed with recurrent right and left indirect inguinal hernia thereby underwent laparoscopic repair with excision of perfix plug (device 1 and 2) and implant of 3dmax light (device 3 and 4).Per op notes, "a periumbilical incision was made.A recurrent right indirect inguinal hernia was identified.A perfix plug (device 1) was noted to be torn away from the lateral abdominal wall and balled up near the internal ring.The perfix plug (device 1) was removed completely.The hernia sac was reduced and separated along with cord lipoma.A 3dmax light (device 3) was placed into the preperitoneal space and secured to cooper's ligament with tack.Left inguinal region was then focused.A perfix plug (device 2) was noted to be torn away from the lateral abdominal wall and away from the internal ring and bunched up near the iliac and femoral vessels.An indirect inguinal hernia was identified.The perfix plug (device 2) was removed.The hernia sac and cord lipoma was reduced.A 3dmax light (device 4) was placed in the preperitoneal space and secured to cooper¿s ligament with tack.".

• 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: 25240955
• Report Number: 1213643-2026-00664
• Device Sequence Number: 13395354
• Product Code: FTL
• UDI-Device Identifier: 00801741016608
• UDI-Public: (01)00801741016608(17)130128(10)HUSA0770
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: 01/28/2013
• Device Catalogue Number: 0112760
• Device Lot Number: HUSA0770
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2008
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 112 KG