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

Model Number	5206502400
Medical Device Problem Codes	Break (1069); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: TESTICULAR PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12520532
• Report Number: 2125050-2021-01359
• Device Sequence Number: 4291043
• Product Code: FAF
• UDI-Device Identifier: 05708932470858
• UDI-Public: 05708932470858
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2025
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR