MAUDE Adverse Event Report: DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL NEEDLELESS SLING; SURGICAL MESH FOR STRESS URINARY INCONTINENCE

Model Number	NL-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Urinary Incontinence (4572); Pelvic Pain (4865)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a needleless sling device implanted in 2008.On two occasions shortly after the surgery, minor resections of the sling material were performed due to erosion.In (b)(6) 2025, the patient reported erosion.The current health of the patient is in good health, with normal age-related problems.The patient has pain and urinary incontinence.
Additional Manufacturer Narrative
The adverse events reported for the patient are identified as potential risks of the device.An investigation has been performed and no more information is available about additional treatments to correct pelvic floor disorders (sui and pop).If any further relevant information is identified, a supplemental mdr will be filed.

• Brand Name: NEEDLELESS SLING
• Common Device Name: SURGICAL MESH FOR STRESS URINARY INCONTINENCE
• Manufacturer (Section D): DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL; poligono industrial mediavega; parcela 2.8; calatayud, zaragoza 50300 ; SP 50300
• Manufacturer (Section G): DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL; polilgono industrial mediavega; parcela 2.8; calatayud, zaragoza 50300 ; SP 50300
• Manufacturer Contact: francisco farrer ; poligono industrial mediavega; parcela 2.8; calatayud, zaragoza 50300 ; SP 50300
• MDR Report Key: 24283719
• Report Number: 3006621295-2026-00001
• Device Sequence Number: 12825450
• Product Code: PAH
• UDI-Device Identifier: 08437007606058
• UDI-Public: 08437007606058
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K063136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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 Model Number: NL-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/06/2026
• 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: 75 YR
• Patient Sex: Female