MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL ZERO ANG 16CM; INFLATABLE PENILE PROSTHESIS

Model Number ES89162400

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming reports and capa review.No trends were noted.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 the available information, this is a (b)(6)-year-old male with a complicated history, however, recently underwent removal, replacement of a non -coloplast penile implant with a circumcision and presents with auto inflation and scrotal swelling concerning for infection.The inflatable device was explanted and replaced with a malleable device.Previous to surgery, pt was seen in er for skin dehiscence two weeks prior.Reported difficulty with deflation and that the pump autoinflates without manipulation.Reported swelling and pain of scrotum and penis.

• Brand Name: TITAN SCROTAL ZERO ANG 16CM
• 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 rivier road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 9125613
• MDR Text Key: 160237013
• Report Number: 2125050-2019-00817
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487320
• UDI-Public: 05708932487320
• 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
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES89162400
• Device Catalogue Number: ES8916
• Device Lot Number: 6526313
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR