MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH PUMP; INFLATABLE PENILE PROSTHESIS

Model Number 5177502400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Purulent Discharge (1812); Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Swelling (2091); Tissue Damage (2104); Discharge (2225); Injury (2348); Deformity/ Disfigurement (2360); No Code Available (3191)

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 the available information, infection occurred.The patient was having rough sex and felt a tear distally to his tissue.The patient had distal pain and scrotal swelling.Once in the scrotum, pus was seen.The 24cm plus 1cm rte on left side was removed.A malleable device was implanted.

Manufacturer Narrative

This follow-up was created to document the returned device, corrected h6 codes and additional event information.Device was received, and the condition of the device received indicated that the device was received to the pathology department in formalin.According to instructions, devices are not to be stored in formalin or other aldehyde-containing antiseptics, disinfectants or antimicrobials.Devices received in prohibited substances will not be evaluated by coloplast due to safety concerns.Therefore, this device receipt has been logged as received, but the device has been discarded and testing will not be performed.Due to the condition of the device received, the lot number was unable to be verified.The device was received in formalin and as such, a review of the device history record, complaint history database, nonconformances and capas could not be completed.

Event Description

Additional information stated, that the 24cm plus 1cm rte was removed on left side and replaced with a malleable.

Manufacturer Narrative

This follow-up was created to document the corrected device information and updated h6 method codes.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, non-conformances and capas revealed no trends for this lot.

• Brand Name: TITAN TOUCH PUMP
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9655584
• MDR Text Key: 177237814
• Report Number: 2125050-2020-00091
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5177502400
• Device Catalogue Number: 517750
• Device Lot Number: 5637161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR