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

Model Number ES28182400

Device Problems Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583); Device Operates Differently Than Expected (2913)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 03/22/2018

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, crossover, sizing.

Manufacturer Narrative

A titan touch pump, two cylinders, and a piece of detached exhaust tubing were received for evaluation.Because quality's examination may not conclusively confirm or disprove the report of crossover or sizing, quality accepts the physician's observations of such as the reason for surgical intervention.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 of the same failure type reported for lot 4364540.Review of nonconforming reports revealed no nonconformance's with lot 4364540 that would have contributed to the reported event.No capas for issues of this type are associated with lot 4364540.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 INFR ZERO ANG 18CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7428382
• MDR Text Key: 105380717
• Report Number: 2125050-2018-00299
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539128
• UDI-Public: 05708932539128
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES28182400
• Device Catalogue Number: ES28182400
• Device Lot Number: 4364540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR