MAUDE Adverse Event Report: COLOPLAST A/S TITAN NARROW SCROT 18CM; INFLATABLE PENILE PROSTHESIS

Model Number	QN89181400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/11/2018
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, infection.
Additional Manufacturer Narrative
This follow-up mdr is created to document the conclusion of the investigation.Requests for the device and for additional information surrounding this event have been made.However, to date neither the device nor the information has been received.Without the benefit of analyzing the device and without the requested information, quality cannot comment on the condition of the device or the events surrounding this incident.If the device or additional information is received, quality will re-evaluate this event in accordance with procedures.However, because quality's examination may not conclusively confirm or disprove the report of infection, quality accepts the physician's observations of such as the reason for surgical intervention.The review of the device lot history records by quality indicates this lot passed sterility testing prior to being released.Based on this knowledge, quality concludes that the device was sterile prior to the device packaging being opened and that the infection originated from source(s) other than the device.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.A review of the complaint history database revealed no significant trends for lot 5258473.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.

• Brand Name: TITAN NARROW SCROT 18CM
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8130968
• Report Number: 2125050-2018-00854
• Device Sequence Number: 1569402
• Product Code: FHW
• UDI-Device Identifier: 05708932323901
• UDI-Public: 05708932323901
• 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: 2018
• 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): 01/08/2019

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: QN89181400
• Device Catalogue Number: QN8918
• Device Lot Number: 5258473
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/21/2019
• 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: 64 YR