MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 18CM; INFLATABLE PENILE PROSTHESIS

Model Number ES29182400

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/05/2018

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 of 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, pinhole in the cylinder.

Manufacturer Narrative

A titan touch pump and cylinders were received for evaluation.Examination and testing of the returned components revealed two separations in the bladder of cylinder 2.The separations appear to be smooth with a central groove indicating contact with a small, sharp instrument such as a needle.No functional abnormalities with the pump or cylinder 1.Because these components were released according to manufacturing and quality control procedures, quality concluded that the observed instrument separation in the bladder of cylinder 2 occurred subsequent to the device packaging being opened.The information received indicated the device was explanted due to a pinhole in the cylinder bladder.Based on the evaluation and information received, quality concluded that the separation most likely occurred inadvertently during the implant procedure.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no further corrective action is required at this time.

• Brand Name: TITAN TOUCH SCRO ZERO ANG 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 river road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 7369894
• MDR Text Key: 103439268
• Report Number: 2125050-2018-00250
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539180
• UDI-Public: 05708932539180
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

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: ES29182400
• Device Catalogue Number: ES29182400
• Device Lot Number: 5852952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/26/2018
• Supplement Dates Manufacturer Received: 03/05/2018
• Supplement Dates FDA Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: 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: 27 YR