MAUDE Adverse Event Report: COLOPLAST A/S TITAN OTR INFRA ZERO ANG; INFLATABLE PENILE PROSTHESIS

Model Number	ESR8182400
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
According to the available information, device malfunction - one side broken, replaced cylinder.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation of the returned device.One cylinder was received for evaluation.Examination and testing revealed the detachment site of the exhaust tube of the cylinder appears to be rough and irregular, indicating sufficient stress was exerted.No functional abnormalities are noted with the cylinder.Quality concluded that the rough and irregular surfaces associated with this detachment site indicates that sufficient stress(s) was exerted on the exhaust tube of the cylinder to separate the site while in-vivo.A separation of this type would then allow the loss of fluid, making the device inoperable.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 OTR INFRA ZERO ANG
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7061075
• Report Number: 2125050-2017-00584
• Device Sequence Number: 16458710
• Product Code: FHW
• UDI-Device Identifier: 05708932487542
• UDI-Public: 05708932487542
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: ESR8182400
• Device Catalogue Number: ESR8182400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR