MAUDE Adverse Event Report: COLOPLAST A/S (OUT)TITAN SCROTAL RESIST 18CM; INFLATABLE PENILE PROSTHESIS

Model Number QS89181000

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Information (3190)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

The device has been received at coloplast; however the evaluation is not yet complete.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 Description

According to the available information, no problems were reported.The patient wanted an upgraded version.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the investigation.A titan pump, two cylinders and a reservoir were received for evaluation.Because quality's examination of the returned components may not conclusively confirm or disprove the report of wanting an "upgraded version", quality accepts the physician's observations as such as the reason for medical intervention.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• Brand Name: (OUT)TITAN SCROTAL RESIST 18CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8694179
• MDR Text Key: 147851233
• Report Number: 2125050-2019-00465
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QS89181000
• Device Catalogue Number: QS8918
• Device Lot Number: 5723565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR