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

Model Number 5187301000

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problem Capsular Contracture (1761)

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.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to available information, this device required explantation due to sustaining an inflation for three months that resulted in a mechanical issue.An inflatable penile prosthesis was implanted and the reservoir was retained.The patient indicated the cylinders were remaining inflated and was unable to inflate or deflate the pump.The physician indicated that the patient has had the device implanted for over 15 years.The physician successfully removed the pump at first with difficulty due to a calcified capsule around pump and tubing.Once the capsule was removed, the pump was able to inflate and deflate.He was unable to remove the rear tip extenders on both sides.Investigation of the tubing and cylinders indicated there was no leak around there.The physician believes the pump and the reservoir were perhaps both capsuled due to how old the implant was placed.Upon explanting the entire device, there was significant calcified tissue all around the device.Due to how long the device was implanted in the patient, the physician opted to place a new device.

• Brand Name: ALPHA I
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 14254583
• MDR Text Key: 290441783
• Report Number: 2125050-2022-00445
• Device Sequence Number: 1
• Product Code: JCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5187301000
• Device Catalogue Number: 518730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 04/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male