MAUDE Adverse Event Report: COLOPLAST A/S TITAN NARROW SCROT 16CM; INFLATABLE PENILE PROSTHESIS

Model Number	QN89161400
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2017
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, a tubing leak at cylinder junction occurred.
Additional Manufacturer Narrative
One cylinder was received for evaluation.Examination and testing of the returned component revealed a separation in the apex of the cylinder.Testing revealed this to be a site of leakage.The separation appears to have a central groove, indicating contact with sharp instrumentation such as a needle.A group of striations were noted on the exhaust tube of the cylinder, indicating contact with unshod instrumentation.Testing revealed these not to be sites of leakage.Because these components were released according to manufacturing and quality control procedures, quality concluded that the observed instrument separation in apex of the cylinder occurred subsequent to the device packaging being opened.Additionally, quality concluded that the small separation could allow for slow fluid loss.Quality concluded that the separation most likely occurred inadvertently during the implant procedure.Additionally, the product development engineer manager examined the returned component and confirmed the observed instrument damage.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 NARROW SCROT 16CM
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 6980844
• Report Number: 2125050-2017-00538
• Device Sequence Number: 10884745
• Product Code: FHW
• UDI-Device Identifier: 05708932323604
• UDI-Public: 05708932323604
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018

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: QN89161400
• Device Catalogue Number: QN89161400
• Device Lot Number: 5127471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 01/09/2018
• 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: 59 YR