MAUDE Adverse Event Report: COLOPLAST A/S TITAN OTR SCROTAL 22CM; INFLATABLE PENILE PROSTHESIS

Model Number QSR9221022

Device Problems Material Erosion (1214); Leak/Splash (1354); Pumping Problem (3016)

Patient Problem No Information (3190)

Event Date 07/01/2019

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, the pump did not work, tubing eroded and there was fluid loss.Another pump was implanted.

Event Description

Additional information received indicated that the patient recalled that prior to the complete failure of the pump, several weeks before, the pump was harder to activate than usual.This was unable to be verified by the physician as the patient had already presented with the system not functioning.

Manufacturer Narrative

The follow-up was created to document the additional information recieved.The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.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 revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.

• Brand Name: TITAN OTR SCROTAL 22CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9417953
• MDR Text Key: 169285830
• Report Number: 2125050-2019-01110
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: QSR9221022
• Device Catalogue Number: QSR922
• Device Lot Number: 1813256
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR