MAUDE Adverse Event Report: COLOPLAST A/S TITAN NB SCROTAL ZERO ANG 16CM; INFLATABLE PENILE PROSTHESIS

Model Number	EN89162400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/15/2019
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, pump would not pump fluid - suspected tubing fracture.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation of the returned device and lot number.A pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a separation in the bladder of cylinder 2.Testing revealed this to be a site of leakage.An aneurysm is noted in the bladder of cylinder 1.Testing revealed this to not be a site of leakage.Partial separations within abrasion are noted on all tubes of the pump.No functional abnormalities were noted with the pump.The information received indicated that the device was functional for over 10 years in the patient.Subsequently, material degradation occurred and progressed enough to cause a separation on the cylinder 2 bladder.Occurrences of this nature are estimated to be relatively rare, and immune responses and in vivo reactions within the human body may largely influence causes for this type of event.An aneurysm in the bladder of cylinder 1 was also noted.Testing confirmed this to not be a site of leakage.As the information received only indicated a possible tubing fracture, quality is unable to determine when the aneurysm may have occurred.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, nonconformances and capas revealed no trends for this lot.

• Brand Name: TITAN NB SCROTAL ZERO ANG 16CM
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek 3050 ; DA 3050
• MDR Report Key: 8339664
• Report Number: 2125050-2019-00079
• Device Sequence Number: 16715534
• Product Code: FHW
• UDI-Device Identifier: 05708932072632
• UDI-Public: 05708932072632
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

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: EN89162400
• Device Catalogue Number: EN8916
• Device Lot Number: 0920370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 05/30/2019
• 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: 76 YR