MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH NB INFR ZERO 18CM; INFLATABLE PENILE PROSTHESIS

Model Number	EN28182400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/21/2018
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, suspected infection.
Additional Manufacturer Narrative
This follow-up mdr is created to document the conclusion of the evaluation.Requests for the explanted prosthesis 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 explant and without the requested information, quality cannot comment on the condition of the device or the events surrounding this incident.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.Review of nonconforming reports revealed no nonconformance with this lot that would have contributed to the event.A review of the complaint database revealed no significant trends in complaints of this type for lot 5768234.The review of the device lot history records by quality assurance 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.If the explanted device or additional information is received, quality will re-evaluate this event in accordance with procedures.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information, no further corrective action is required at this time.

• Brand Name: TITAN TOUCH NB INFR ZERO 18CM
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7516023
• Report Number: 2125050-2018-00366
• Device Sequence Number: 16526047
• Product Code: FHW
• UDI-Device Identifier: 05708932072526
• UDI-Public: 05708932072526
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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: EN28182400
• Device Catalogue Number: EN28182400
• Device Lot Number: 5768234
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2018
• Supplement Date Received by Manufacturer: 04/21/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/14/2018
• 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: 63 YR