MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN OTR SCROTAL 14CM; INFLATABLE PENILE PROSTHESIS

Model Number QSR9141400

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 05/23/2018

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, malfunction - stuck valve.

Manufacturer Narrative

Attempts have been made to obtain additional information surrounding this event.However, additional information has not been received.If additional information becomes available, the complaint will be re-evaluated according to procedures.Quality was unsuccessful in securing the device for evaluation.Without the benefit of analyzing the device, quality cannot confirm any observations and cannot comment on the condition of the prosthesis.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 2079363.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 14CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7624789
• MDR Text Key: 111856798
• Report Number: 2125050-2018-00476
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

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
• Device Operator: Lay User/Patient
• Device Model Number: QSR9141400
• Device Catalogue Number: QSR9141400
• Device Lot Number: 2079363
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 05/23/2018
• Supplement Dates FDA Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR