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

Model Number	ESR8222400
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received at coloplast; however the evaluation is not yet complete.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to the available information, malfunction.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation of the returned device.Titan otr pump, two cylinders and detached inlet tube with connector were received for evaluation.Examination and testing of the returned components revealed partial separation within abrasion on the exhaust tube of cylinder 2.Testing revealed these to not be sites of leakage.Abrasion was noted on all tubes of the pump and detached inlet tube with connector.No functional abnormalities were noted with any of the returned components.Because the available information did not indicate what factors may have contributed to the reported malfunction, and because no functional abnormalities were noted, quality cannot determine the cause of this reported event.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformance's and capas revealed no trends for this lot.

• Brand Name: (2BO)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: 8773191
• Report Number: 2125050-2019-00557
• Device Sequence Number: 19342423
• Product Code: FHW
• UDI-Device Identifier: 05708932487580
• UDI-Public: 05708932487580
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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: ESR8222400
• Device Catalogue Number: ESR822
• Device Lot Number: 3902940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 10/17/2019
• 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: 65 YR