MAUDE Adverse Event Report: COLOPLAST A/S (2BO)ALPHA I 18CM SCROTAL; INFLATABLE PENILE PROSTHESIS

Model Number 5187401000

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 04/18/2017

Event Type  Injury  

Manufacturer Narrative

A pump, two cylinders and reservoir were received for evaluation.Examination and testing of the returned components revealed the pump exhaust tubes and inlet tube were overlapping each other while in-vivo.This positioning, in combination with device usage over time, could result in sufficient stress(s) to cause the eventual separation of the pump inlet and longer pump exhaust tubes while in-vivo.Separations of these types would then allow the loss of fluid, making the device inoperable.In addition, as the device had been implanted for over 20 years.

Event Description

According to the available information, tubing broken.

• Brand Name: (2BO)ALPHA I 18CM SCROTAL
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 6739066
• MDR Text Key: 80867728
• Report Number: 2125050-2017-00248
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 07/21/2017

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: 5187401000
• Device Catalogue Number: 5187401000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR