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

Model Number ES28181022

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/16/2018

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, malfunction - possible hole in cylinder.

Manufacturer Narrative

This follow up mdr is created to document the conclusion of the investigation, the additional event information, and the corrected implant date.A titan touch pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed surface abrasion on all tubes and all strain relief of the pump.No functional abnormalities are noted with the pump.Two separations are noted in the bladder of cylinder #2.Testing revealed these to be sites of leakage.The separations appear to have a central groove, indicating contact with sharp instrumentation such as a needle.The information received indicated a malfunction - possible hole in cylinder.The information did not indicate when the observed instrument separation occurred.Because the expected use of this device combined with the observed separation would have resulted in an earlier detected fluid loss, quality cannot determine the root cause of this event.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no additional complaints reported for lot 5533058.Review of nonconforming reports revealed no nonconformance's with lot 5533058 that would have contributed to the reported event.No capas for issues of this type are associated with lot 5533058.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.

Event Description

According to the available information, malfunction - possible hole in cylinder.Additional information received indicated the surgeon put a suture through the cylinder.It is unknown when this occurred.

• Brand Name: TITAN TOUCH INFR 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: stephanie perryman ; 1601 west rivier road north; minneapolis, MN 55411 ; 6124345685
• MDR Report Key: 7418201
• MDR Text Key: 105095850
• Report Number: 2125050-2018-00276
• 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,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES28181022
• Device Catalogue Number: ES28181022
• Device Lot Number: 5533058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2018
• 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: 66 YR