MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN OTR SCROTAL 20CM; INFLATABLE PENILE PROSTHESIS

Model Number QSR9201400

Device Problem Hole In Material (1293)

Patient Problem No Information (3190)

Event Date 04/13/2018

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.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, 0.5cm hole in reservoir.

Manufacturer Narrative

Requests for the explanted prosthesis and for additional information surrounding this event have been made.However, to date neither the device nor the information has been received.Without the benefit of analyzing the explant and without the requested information, quality cannot comment on the condition of the device or the events surrounding this incident.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.Review of nonconforming reports revealed no nonconformance with this lot that would have contributed to the event.A review of the complaint database revealed no significant trends in complaints of this type for lot 2719049.The most likely root cause of the event cannot be determined at this time.If the explanted device or additional information is received, quality will re-evaluate this event in accordance with procedures.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, no further corrective action is required at this time.

• Brand Name: (2BO)TITAN OTR SCROTAL 20CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7525683
• MDR Text Key: 108632451
• Report Number: 2125050-2018-00383
• 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: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QSR9201400
• Device Catalogue Number: QSR9201400
• Device Lot Number: 2719049
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR