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

Model Number	EN88162400
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/28/2019
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.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to the available information, there was a leak near the top of the pump.The device was not inflating properly.The pump was exchanged.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation of the returned device and the clarification on the date the event was observed.A titan pump was received for evaluation.Examination and testing of the returned component revealed a separation in the pump body between the first and second rib at the base of the pump.Testing revealed this to be a site of leakage.Microscopic examination of the surfaces revealed them to be rough and irregular, indicating stress was exerted.Abrasion was noted on the longer exhaust and inlet tube of the.Based on examination of the returned product, it was concluded that while in-vivo the longer exhaust tube and inlet tube of the pump had overlapped and abraded against one another.It was further concluded that the rough and irregular surfaces associated with the pump body separation at the base of the pump indicated that sufficient stress(s) may have been exerted on the on this site to separate it while in-vivo.A separation of this type would then allow the loss of fluid, making the device inoperable.A review of the device history record confirmed the devices from this lot met all specifications prior to release and no anomalies were noted during production.A review of the complaint history database, nonconformance's and capas revealed no trends for this lot.
Event or Problem Description
This event was first observed in (b)(6) 2019.

• Brand Name: TITAN NB INFRA ZERO ANG 16CM
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8898447
• Report Number: 2125050-2019-00670
• Device Sequence Number: 16208155
• Product Code: FHW
• UDI-Device Identifier: 05708932072595
• UDI-Public: 05708932072595
• 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: 2019
• 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): 12/11/2019

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: EN88162400
• Device Catalogue Number: EN8816
• Device Lot Number: 6663007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 12/17/2019
• 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: 67 YR