MAUDE Adverse Event Report: ETHICON INC. PRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY; MESH, SURGICAL, POLYMERIC

Catalog Number	PHSM1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Date of Event	01/01/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # = >(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Operative reports: operative report (b)(6) 2014.Clinical history: patient presented with pain in the left inguinal region for several weeks, worsened by change of position and physical exertion.Ultrasound confirmed a left femoral hernia that was uncomplicated.Operative technique: patient under general anaesthesia in supine position.Approximately 5 cm incision parallel to the left inguinal arch.Dissection of the cord after division of the external oblique aponeurosis.No hernial sac found during cord dissection.Opening of the transversalis fascia and reduction of a small femoral hernia.Placement of a phs-type prosthesis fixed to the pubic tubercle, to the inguinal ligament and to the conjoint tendon with interrupted prolene 3/0 sutures.Haemostasis checked.Closure of the external oblique aponeurosis with a running vicryl 2/0 suture.Interrupted vicryl 2/0 sutures in the subcutaneous tissue.Monocryl 3/0 resorbable suture to the skin.Steri-strips.Dressing.On (b)(6) 2014: reason for admission: surgical management of a symptomatic left femoral hernia.Medical history: suspected ehlers/danlos disease (joint laxity, fragile skin, visible chest vessels, repeated bleeding problems, bruising, heavy menorrhagia in adolescence, multiple postpartum hemorrhages, bleeding after dental extraction).History of illness: the patient consulted for left inguinal pain evolving for 3 weeks, worse when standing and after exertion.Ultrasound confirmed a symptomatic uncomplicated left femoral hernia and an asymptomatic, uncomplicated right inguinal hernia.Indication for left femoral hernia repair with placement of a non-resorbable prosthesis.Procedure: surgery performed on (b)(6) 2014 by the surgeon: left femoral hernia repair with placement of a prosthesis via open approach.Postoperative course: uncomplicated.Discharge: the patient was discharged the day after surgery.Discharge medications/instructions included: resume usual treatment paracetamol 1 g every 6 hours as needed contramal 50 mg every 6 hours as needed lovenox 0.4 ml: one injection daily for 6 days with platelet count monitoring twice weekly during treatment nurse visits at home for dry dressing care every 2 days until complete healing follow-up: patient to be reviewed by her surgeon in one month.Conclusion: left femoral hernia repair with placement of a prosthesis on (b)(6) 2014.Bilateral femoral hernia.Suspected ehlers/danlos disease under investigation.
Event or Problem Description
It was reported that a patient underwent a femoral hernia repair procedure (b)(6) 2014.Postoperative course was uncomplicated.The patient was discharged the day after surgery with medications.The patient developed a recurrent left inguinal hernia that was confirmed on ultrasound and underwent a repair on (b)(6) 2015.Current patient status: severe pain in the left inguinal area (two hernia meshes overlapping).The pains that required management at the university hospital pain centre are on the left, where the two prostheses overlap.Recurrence.Quality of life extremely degraded.Life on hold, and it is getting worse.These prostheses have been in place for 10 years and i have been struggling ever since.Sometimes the pain level is extreme.Daily suffering requiring use of versatis patches, analgesics, psychological follow-up.Use of peristeen plus laxatives.Antihistamines, anxiolytics and hypnotics.No additional information was provided.
Additional Manufacturer Narrative
Product complaint: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected information: h4.Additional information: h6.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.

• Brand Name: PRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): J-PAC; 25 centre road; somersworth NH 03878
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24283550
• Report Number: 2210968-2026-01396
• Device Sequence Number: 18607429
• Product Code: FTL
• UDI-Device Identifier: 10705031048997
• UDI-Public: (01)10705031048997(17)190131(10)26816-06
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K180829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: 01/31/2019
• Device Catalogue Number: PHSM1
• Device Lot Number: 26816-06
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2014
• 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: Unknown