MAUDE Adverse Event Report: COLOPLAST A/S TOROSA; TESTICULAR PROSTHESIS

Model Number 5206502400

Device Problems Break (1069); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2021

Event Type  Injury  

Manufacturer Narrative

A torosa implant was received for analysis.A separation was noted in the suture tab of the testicular.This was not a site of leakage.The surfaces appeared to be straight, indicating contact with instrumentation.No functional abnormalities were noted with the testicular.Based on examination of the returned product, the device passed all testing.The suture tab was confirmed to be separated and the separation ends were straight and not rigid.Based on the information received the initial suture may had inadvertently been tied too tight and then separated the suture tab area, which was noted by the straight detachment edges.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

Event Description

According to the available information the saline testicular device was implanted and replaced on (b)(6) 2021 due to the suture tab broke.The patient received the initial implant, filled properly.The patient complained, "too hard, wrong position".Additional information received from the territory manager noted that in the recovery room, the patient complained about the torosa being too hard and didn¿t like the way that it felt.The implant was filled per recommended fill volumes.The torosa was sutured in place.From what the doctor described the patient said it didn¿t quite feel right.The doctor couldn¿t detect anything out of the ordinary, but the patient was persistent so he decided to take the patient back to the or just an hour or so later (since the patient was still at the hospital in recovery).Upon opening the same incision, it was discovered that the suture tab was torn.The doctor questioned if he tied the suture too tight around the tab to cause the tear but it was not clear what caused the tear.A second torosa was prepped and replaced, suturing it into place.

• Brand Name: TOROSA
• Type of Device: TESTICULAR PROSTHESIS
• 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12520532
• MDR Text Key: 273755046
• Report Number: 2125050-2021-01359
• Device Sequence Number: 1
• Product Code: FAF
• UDI-Device Identifier: 05708932470858
• UDI-Public: 05708932470858
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5206502400
• Device Catalogue Number: 5206502
• Device Lot Number: 7404459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR