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

Catalog Number	0112760
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2017- patient was diagnosed with right femoral hernia thereby underwent open repair with implant of perfix plug (device 1 and device 2).Per op notes, "a skin incision was made on the previous c-section incision.External oblique was opened.A femoral hernia was identified.It was dissected out of the canal.A perfix plug (device 1) was placed into the canal in the location of the defect and secured with sutures.The proximal defect ends another perfix plug (device 2) were placed into the opening and anchored in place with sutures together for better coverage." on (b)(6) 2021- patient was diagnosed with left inguinal hernia, recurrent right inguinal hernia, umbilical hernia and pain in right groin thereby underwent robotic assisted laparoscopic repair and open repair for umbilical hernia with partial explant of perfix plug (device 1 and device 2) and implant of bard flat mesh (device 3 and device 4).Per op notes, "in the left groin a small indirect defect was identified.On the left a peritoneal incision was made in a transverse direction.The peritoneum was dissected and the hernia sac was reduced.A large lipoma which was adherent to the round ligament was reduced and dissected free.A bard flat mesh (device 3) was placed with the inferior medial corner overlapping amply the pubis tubercle and was secured with sutures to the pubic tubercle along its inferior medial aspect and to the anterior abdominal wall along the superior aspect.On the right-side lysis of adhesions was performed to separate the omental adhesions from the area of inguinal ring.The previously placed perfix plug (device 1 and device 2) which was found to be wedged between the inferior epigastric vessels and the inguinal floor, both meshes were excised.Removal of the mesh created a defect in the inguinal floor which was repaired by placing a bard flat mesh (device 4) and was secured with sutures.To repair the umbilical hernia the fascial edges were cleaned with dissection both anteriorly and posteriorly in all directions.The fascia was closed 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-jun-2016) 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.

• 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: 50272594
• Report Number: 1213643-2026-01043
• Device Sequence Number: 18782586
• Product Code: FTL
• UDI-Device Identifier: 00801741016608
• UDI-Public: (01)00801741016608(17)210628(10)HUAT1748
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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: 06/28/2021
• Device Catalogue Number: 0112760
• Device Lot Number: HUAT1748
• 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: 08/05/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2016
• 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