MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 22CM; INFLATABLE PENILE PROSTHESIS

Model Number	ES29222400
Medical Device Problem Codes	Mechanical Jam (2983); Pumping Problem (3016)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/02/2019
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, hard pump.
Event or Problem Description
Additional information indicated the reported complaint was observed in (b)(6) 2019.
Additional Manufacturer Narrative
This follow-up mdr is created to document the additional event information, corrected device information, and the conclusion of the investigation.A titan touch pump was the sole component received for evaluation.Examination and testing of the returned component revealed no functional abnormalities.The information received indicated the a "hard pump", but because no functional abnormalities were noted with the returned components, quality cannot confirm the complaint as reported.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, nonconformance's and capas revealed no trends for this lot.

• Brand Name: TITAN TOUCH SCRO ZERO ANG 22CM
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8660651
• Report Number: 2125050-2019-00436
• Device Sequence Number: 11331441
• Product Code: FHW
• UDI-Device Identifier: 05708932539166
• UDI-Public: 05708932539166
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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: ES29222400
• Device Catalogue Number: ES2922
• Device Lot Number: 5860417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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: 79 YR