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

Model Number QS89181400

Device Problems Break (1069); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 01/31/2019

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, malfunction.Patient had narrow w/pump riding high.Tubing break just above pump.Put in standard size and larger reservoir.Implant not coming back, per doctor.

• Brand Name: (2BO)TITAN SCROTAL 18CM
• 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: 8382020
• MDR Text Key: 137534377
• Report Number: 2125050-2019-00148
• 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: company representative
• Type of Report: Initial
• Report Date: 02/25/2019

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: QS89181400
• Device Catalogue Number: QS8918
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 69 YR