MAUDE Adverse Event Report: COLOPLAST A/S VIRTUE 2; SURGICAL MESH

Model Number 5002041022

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146); Tingling (2171)

Event Date 10/17/2017

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 of 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, a (b)(6) -year old patient experienced perineal & scrotal pain and scrotal paresthesia after virtue procedure.Date of procedure : (b)(6) 2017.Date of onset event : (b)(6) 2017.Description of the event : on (b)(6) 2017, the patient experienced pain localized on operative site.On (b)(6) 2017 (first visit after virtue surgery) : the patient reported scrotal pain and paresthesia that should disappear according the investigator.On (b)(6) 2017 : the patient reported a painful segment at the level of the right thigh which corresponds to the sling that is palpable.On (b)(6) 2018 : no more pain and paresthesia.Treatment: paracetamol and tramadol 50 mg twice per day during 5 days.On (b)(6) 2017: prescription of pelvic-perineal reeducation.Status of the event : resolved on (b)(6) 2018 (device still implanted).According the investigator, the event is related to the procedure.

Manufacturer Narrative

This report is being duplicated and re-submitted with the correct report number per request from fda.The email request is attached to this submission, along with a pdf of the original report.Method code(s): 3263 - 3331.Result code(s): 3221.Conclusion code(s): 92.This follow-up mdr is created to document the conclusion of the evaluation.The device remains implanted.Without the benefit of analyzing the device, quality cannot confirm any observations and cannot comment on the condition of the prosthesis.If the device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.However, because quality's examination may not conclusively confirm or disprove the report of pain and paresthesia, quality accepts the physician's observations.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information, and because the device is not available for evaluation, no further corrective action is required at this time.

• Brand Name: VIRTUE 2
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7418154
• MDR Text Key: 105097404
• Report Number: 2125050-2018-00286
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• PMA/PMN Number: K101297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

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
• Device Operator: Physician
• Device Model Number: 5002041022
• Device Catalogue Number: 5002041022
• Device Lot Number: 5169858
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 03/14/2018
• Supplement Dates FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 80