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	Pain (1994); Hernia (2240); Depression (2361); Ambulation or Postural Difficulties (2544); Neuralgia (4413); Dyspareunia (4505)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported patient alleges experiencing multiple complications including left inguinal hernia recurrence, severe pain in his groin and testicles post implant of perfix plugs.Patient has undergone several scans and ultrasounds.Based on the information available to date, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's postoperative complication.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Pain and hernia recurrence are listed in the adverse reactions section, as possible complications.This emdr represents the perfix plug (device 2).An additional emdr was submitted to represent the perfix plug (device 1).Note: section a through f - the subject device was not available for evaluation.Based on the information provided and without having the sample to evaluate at this time, no conclusions can be made.Review of manufacturing records shows product was made to specification.
Event or Problem Description
As per ansm report (b)(4) in summary: date of occurrence: (b)(6) 2019.Description of the incident: (b)(6) 2019 "since waking up following outpatient surgery to repair a bilateral inguinal hernia using plugs (perfix plug devices lot numbers hucy1469/hudp0501), my son has been suffering from severe pain in his groin and testicles, which is why he remained in hospital for a day." clinical consequences and current condition: "since then, the pain has never stopped, particularly on the left side, but today it is getting worse on the right side (like electric shocks or stabbing pains) in my lower abdomen, groin, private parts, and thigh.Over the years, i have had several scans and ultrasounds, often with conflicting results.Over the years, other symptoms have developed, some of which have been present since the beginning, including insomnia, exhaustion, low mood, and diffuse pain throughout the body.So, normal biological tests, normal rheumatological tests (multiple x-rays, etc., with no clear conclusions).He saw three other surgeons who explained that the plugs could not be removed because it was too dangerous.The last scan in 2024 showed a small recurrence on the left side.Consequences: fear, inability to remain in a static position for long periods of time, cessation of regular sports activities, significant deterioration in personal and professional quality of life, breakup with partner, intimate relations too painful.Uncertainty about the future, life plans on hold, depression, isolation, loss of confidence in the medical profession, feeling of abandonment, and unpredictable pain levels 8 to 10.Every day he regrets having had the operation because previously it was just a minor discomfort.It never stopped, particularly on the left, but now it is getting worse on the right (like electric shocks or knife stabs) in the lower abdomen and groin, private parts and thigh." abdominal-pelvic ultrasound (b)(6) 2021: indication: post-operative pain from bilateral inguinal hernia.Suspected associated left spiegel hernia.Results: examination of the left abdominal wall reveals no obvious parietal hernia.In the bilateral inguinal region, two echogenic, pseudonodular formations measuring 23.5 mm on the right and 20 mm on the left.Conclusion: the question of bilateral inguinal hernia recurrence arises.No parietal hernia visible, particularly on the left side.Further ct scan recommended abdominal-pelvic ultrasound - inguinal ultrasound (b)(6) 2023: no pelvic mass syndrome detectable under examination conditions.At the inguinal level, no ultrasound evidence of hernia recurrence.Abdominal and pelvic ct scan (b)(6) 2024: indication: postoperative pain following bilateral inguinal hernia repair in 2019.Investigation for recurrence or displacement of prosthetic material results: evidence of an uncomplicated left inguinal hernia with presence of jejunal loops within it.Changes in the right inguinal canal, with no evidence of recurrence.Conclusion: recurrence of left inguinal hernia with jejunal loops within the hernial sac, uncomplicated to date this mdr represents perfix plug (lot number hudp0501).

• 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: 24469911
• Report Number: 1213643-2026-00252
• Device Sequence Number: 21363828
• Product Code: FTL
• UDI-Device Identifier: 00801741016608
• UDI-Public: (01)00801741016608(17)240128(10)HUDP0501
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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: 01/28/2024
• Device Catalogue Number: 0112760
• Device Lot Number: HUDP0501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2019
• 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: Disability
• Patient Sex: Male