MAUDE Adverse Event Report: COLOPLAST A/S VIRTUE MALE SLING SYSTEM; SURGICAL MESH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Urinary Retention (2119); Hematuria (2558)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.(b)(4).

Event Description

Valenzuela rj, ziegelmann mj, hillelsohn jh, farrell mr, kent ma, levine la.Preliminary outcomes of the male urethral "mini-sling": a modified approach to the andrianne mini-jupette procedure with penile prosthesis placement for climacturia and mild stress urinary incontinence.J sex med.2019 aug;16(8):1310-1317.Doi: 10.1016/j.Jsxm.2019.04.009.Epub 2019 may 17.Pmid: 31109775.According to the available information, of 36 patients implanted with virtue and implantable penile prostheses, transient urinary retention occurred in two patients.One patient experienced prolonged urinary retention requiring catheterization.His catheter was removed while traveling outside of the united states.He presented with new hematuria and urinary urgency approximately three months after surgery.Cystoscopy revealed mesh erosion.The patient was taken to the operating room for mesh excision and primary urethral repair.The prosthesis was left in place and is currently activated.The patient is doing well without evidence of urethral stricture.One additional patient reported persistent scrotal pain five months after surgery.Cystoscopy revealed a normal urethra with satisfactory urethral compression during inflation and no evidence of erosion.The pain improved with anti-inflammatory drugs and daily device cycling.

• Brand Name: VIRTUE MALE SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usauv autumn valentine ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 10950922
• MDR Text Key: 219883337
• Report Number: 2125050-2020-01211
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention