MAUDE Adverse Event Report: DESARROLLO E INVESTIGACIÓN MÉDICA ARAGONESA S.L. REMEEX SYSTEM; SURGICAL MESH FOR STRESS URINARY INCONTINENCE

Model Number	SREM-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Fever (1858); Inflammation (1932); Pain (1994); Medical device site infection (4845)
Date of Event	02/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although it is clear the patient has suffered adverse events identified as a potential risks of the device, it is not possible to confirm the origin of the infection detected in 2025, precisely 8 years after the initial device implantation.Furthermore, patient has undergone multiple medical treatments since receiving the remeex system device (between the years of 2017 and 2023) to correct pelvic floor disorders (sui and pop).A review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
The patient had a remeex system device implanted in 2017.In (b)(6) 2025, the patient reported pain and inflammation of the suprapubic implant component, with an accompanying fever for two days.The patient presented biological inflammatory syndrome with a scan confirming inflammation over the implanted component.Patient was treated with antibiotic therapy and partial explantation of the device (suprapubic implant component which allows for continuous tension adjustment of the sling).

• Brand Name: REMEEX SYSTEM
• Common Device Name: SURGICAL MESH FOR STRESS URINARY INCONTINENCE
• Manufacturer (Section D): DESARROLLO E INVESTIGACIÓN MÉDICA ARAGONESA S.L.; polígono industrial mediavega; parcela 2.8; calatayud, zaragoza 50300 ; SP 50300
• Manufacturer (Section G): DESARROLLO E INVESTIGACIÓN MÉDICA ARAGONESA S.L.; polígono industrial mediavega; parcela 2.8; calatayud, zaragoza 50300 ; SP 50300
• Manufacturer Contact: francisco farrer ; polígono industrial mediavega; parcela 2.8; calatayud, zaragoza 50300 ; SP 50300
• MDR Report Key: 22029284
• Report Number: 3006621295-2025-00001
• Device Sequence Number: 15562621
• Product Code: OTN
• UDI-Device Identifier: 08437007606027
• UDI-Public: 08437007606027
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K033310
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2025

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: 06/01/2022
• Device Model Number: SREM-01
• Device Lot Number: CRSF20170620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 74 KG