MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN OTR SCROT ZERO ANG; INFLATABLE PENILE PROSTHESIS

Model Number	ESR9162400
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
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 titan otr was explanted due to torn tubing near pump.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation of the returned device and additional device information received.A titan touch pump, two cylinders and reservoir were received for evaluation.Examination and testing of the returned components revealed no functional or visible abnormalities with the pump, cylinders or reservoir.Because the available information did not indicate what factors may have contributed to the reported event of "torn tubing near pump," and because no functional abnormalities were noted, quality cannot determine the true cause of this reported 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.Review of nonconforming reports revealed no nonconformance with this lot that would have contributed to the event.A review of the complaint database revealed no significant trends in complaints of this type for lot 3733353.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, and because the device is not available for evaluation, no further corrective action is required at this time.

• Brand Name: (2BO)TITAN OTR SCROT ZERO ANG
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7029309
• Report Number: 2125050-2017-00571
• Device Sequence Number: 1183670
• Product Code: FHW
• UDI-Device Identifier: 05708932487641
• UDI-Public: 05708932487641
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

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: ESR9162400
• Device Catalogue Number: ESR9162400
• Device Lot Number: 3733353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 06/19/2018
• 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: 57 YR