MAUDE Adverse Event Report: COLOPLAST A/S UNKNOWN INFLATABLE PROSTHESIS; INFLATABLE PENILE PROSTHESIS

Device Problems Deflation Problem (1149); Inflation Problem (1310); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

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, kinked tubing.The device was revised.The physician reported that the patient had the device in for at least 13 years and noticed over the last year that he had difficulty with inflation and deflation.On exam, was found that the patient most likely had a kink in the tubing which was restricting fluid transfer from the pump to the reservoir.Upon surgical exploration, the kink was actually at the point of the straight connector going to the reservoir.This was simply excised and reconnected with right angle connector without difficulty.Patient is having no complaints post-operatively and it is functioning normally.

Event Description

The device was not received for evaluation as it remains implanted.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.As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.

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.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• Brand Name: UNKNOWN INFLATABLE PROSTHESIS
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10436086
• MDR Text Key: 203816420
• Report Number: 2125050-2020-00742
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR