MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 14CM; INFLATABLE PENILE PROSTHESIS

Model Number	ES29142400
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A titan touch pump and two cylinders were received for evaluation.Because quality's examination of the returned components may not conclusively confirm or disprove the report of infection, quality did not perform a microscopic examination.The review of the device lot history records by quality assurance indicates this lot passed sterility testing prior to being released.Based on this knowledge, quality concludes that the device was sterile prior to the device packaging being opened and that the infection originated from source(s) other than the device.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 (b)(4).Exemption #e2006011.
Event or Problem Description
According to the available information, infection - scrotal at pump.

• Brand Name: TITAN TOUCH SCRO ZERO ANG 14CM
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 6741849
• Report Number: 2125050-2017-00294
• Device Sequence Number: 685006
• Product Code: FHW
• UDI-Device Identifier: 05708932539166
• UDI-Public: 05708932539166
• 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: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2017

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: ES29142400
• Device Catalogue Number: ES29142400
• Device Lot Number: 4751579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 07/25/2017
• 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: 70 YR