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

Model Number 5002041022

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

Patient Problems Wound Dehiscence (1154); Urinary Retention (2119)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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.

Event Description

According to the available information, the patient experienced urinary retention and wound "disunion" after the virtue procedure.The patient did not urinate after catheter removal perioperatively.Post-void-residual was 448 milliliters.An indwelling foley catheter was placed for three days to drain the urine.The patient was reviewed on (b)(6) 2020, at which time wound "disunion" was identified.The wound was clean with no purulent discharge.Augmentin was given, as well as algoterin patch for three weeks until healing.The event was resolved on (b)(6) 2020.The event was related to the procedure.

• 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: 11158123
• MDR Text Key: 226550223
• Report Number: 2125050-2021-00044
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• PMA/PMN Number: K113496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5002041022
• Device Catalogue Number: 500204
• Device Lot Number: 6199186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 70