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

Catalog Number	0112760
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Scar Tissue (2060); Hernia (2240)
Date of Event	05/03/2019
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-apr-2013) 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) 2013 - patient was diagnosed with recurrent femoral hernia thereby underwent open repair with excision of mesh and implant of perfix plug (device 1).Per op notes, "an incision was made through the previous incision.A very large firm mass in the area consistent with a piece of mesh within the subcutaneous tissue was noted.The unknown mesh was completely removed which exposed the femoral canal.A large hernia sac was identified and dissected free.A large piece of omentum incarcerated with the hernia was noted and reduced.It was then closed with suture.A very large femoral hernia was identified.A perfix plug (device 1) was placed and secured with suture." (note: the prior mesh visualized during this procedure was unknown).On (b)(6) 2014 - patient was diagnosed with recurrent left femoral hernia thereby underwent laparoscopic converted to open repair with excision of perfix plug (device 1) and implant of perfix plug (device 2).Per op notes, "a skin incision was made below the umbilicus.A lot of filmy adhesions were noted.Femoral hernia was identified.An incision was made through her previous inguinal incision for open repair.A very contracted piece of mesh was noted and dissected free.The perfix plug (device 1) was excised.A very large hernia sac was identified and completely freed up and then closed off with suture.A perfix plug (device 2) was placed and secured with suture.The hernia sac was reduced and it was densely adherent.A piece of synthetic mesh was then placed in the preperitoneal space and tacked below the femoral defect." on (b)(6) 2019 - patient was diagnosed with recurrent left inguinal hernia and primary right femoral hernia and right inguinal hernia thereby underwent robotic assisted repair with implant of ventralight st mesh (device 3 and 4).Per op notes, "a small incision was made.The left inguinal hernia and right femoral hernia were identified.The left inguinal hernia had scar tissue from the previous mesh and appeared to have a plug down in the femoral area.The mesh was lifted off the transverse.Some enlarged nodes in the left groin was noted and two of these were excised.The indirect space was imbricated with suture and then the ventralight st mesh (device 3) was placed and secured to cooper¿s ligament with suture.The right side was then incised with a curvilinear incision.The femoral hernia was reduced and then closed with suture.The ventralight st mesh (device 4) was placed and secured to cooper¿s ligament with suture.".

• 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: 25371607
• Report Number: 1213643-2026-00707
• Device Sequence Number: 13060667
• Product Code: FTL
• UDI-Device Identifier: 00801741016608
• UDI-Public: (01)00801741016608(17)180528(10)HUXD2362
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: 05/28/2018
• Device Catalogue Number: 0112760
• Device Lot Number: HUXD2362
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2013
• 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: 37 YR
• Patient Sex: Female