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

Model Number	QN89161400
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/04/2018
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 corrected implant date and the evaluation of the returned device.A titan pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a separation in the pump body/bulb and both cylinder bladders.Testing revealed these to all be sites of leakage.Microscopic examination of the surfaces revealed them to have uniform striation, indicating contact with sharp instrumentation.Abrasion was noted on the longer exhaust tube and inlet tube of the pump.Very limited testing could be completed on the returned components.As not all testing could be completed, due to the as received condition, quality cannot determine the cause of the 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, nonconformances and capas revealed no trends for this lot.

• Brand Name: (MPO)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: 8533882
• Report Number: 2125050-2019-00286
• Device Sequence Number: 13831785
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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: QN89161400
• Device Catalogue Number: QN8916
• Device Lot Number: 4454970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/26/2019
• 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: 58 YR