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

Model Number	5206502400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional 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.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to the available information, suture hurting patient (stabbing pain).Prosthesis replaced.Explanted prosthesis discarded.
Event or Problem Description
This follow-up mdr is created to document the additional event information received for record#: (b)(4).According to the available information the inflatable penile prosthesis was removed / replaced on (b)(6) 2020 due to pain.Additional information received from the territory manager indicated: ¿suture hurting patient (stabbing pain).Prosthesis replaced.Explanted prosthesis discarded.The device was not received for evaluation as it was discarded.As examination of the device may not conclusively confirm or disprove the report of pain quality accepts the physician¿s observations as to the reason for surgical intervention.As no lot# was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.
Additional Manufacturer Narrative
Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.H3 other text: the device was not received for evaluation.

• Brand Name: TOROSA
• Common Device Name: TESTICULAR PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10495988
• Report Number: 2125050-2020-00800
• Device Sequence Number: 3117846
• Product Code: FAE
• UDI-Device Identifier: 05708932470858
• UDI-Public: 05708932470858
• Combination Product (Y/N): N
• PMA/510(K) Number: P020003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2020

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
• Operator of Device: Health Professional
• Device Model Number: 5206502400
• Device Catalogue Number: 520650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 10/19/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 48 YR