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

Model Number	QN89161400
Health Effect - Clinical Codes	No Information (3190); No Code Available (3191)
Date of Event	06/12/2017
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 occurence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.(b)(4).Effective immediately, we are required to electronically submit individual adverse event reports for these product codes.Exemption #e2006011.
Event or Problem Description
According to the available information, incorrect size.
Additional Manufacturer Narrative
This follow-up mdr is created to document the conclusion of the evaluation.A device was received in a condition making evaluation impossible.However, because quality's examination may not conclusively confirm or disprove the report of incorrect size, quality accepts the physician's observations of such as the reason for surgical intervention.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 3634142.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 NARROW SCROT 16CM
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 6739028
• Report Number: 2125050-2017-00185
• Device Sequence Number: 13698873
• 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: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

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: QN89161400
• Device Catalogue Number: QN89161400
• Device Lot Number: 3634142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 06/18/2018
• 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: 42 YR