MAUDE Adverse Event Report: COLOPLAST A/S TITAN; INFLATABLE PENILE PROTHESIS

Model Number	ESR8202400
Medical Device Problem Codes	Fluid/Blood Leak (1250); Pumping Problem (3016)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
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.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Event or Problem Description
According to the available information, though not verified, initial procedure done in 2013.Device stopped pumping up a few months ago.Device unable to cycle, makes squeaking sound consistent with a leak.Upon explant, there was a leak at the tubing from the pump to cylinder.Drained and retained old reservoir.Put a new reservoir on left side.Reservoir filled with 100ml.Device removed and replaced.
Additional Manufacturer Narrative
According to the available information this inflatable penile prosthesis was implanted in 2013 and removed/replaced on (b)(6) 2021 due to the device stopped pumping up.Device unable to cycle, makes squeaking sound consistent with a leak.Upon explant, there was a leak at the tubing from the pump to cylinder.The explanted prosthesis was not returned for evaluation.Without the benefit of analyzing the explant, quality cannot confirm any observations and cannot comment on the condition of the prosthesis.If the explanted device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.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.
Event or Problem Description
Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.

• Brand Name: TITAN
• Common Device Name: INFLATABLE PENILE PROTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11292101
• Report Number: 2125050-2021-00107
• Device Sequence Number: 610688
• Product Code: FHW
• UDI-Device Identifier: 05708932487566
• UDI-Public: 05708932487566
• 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 Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ESR8202400
• Device Catalogue Number: ESR820
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 08/18/2021
• Patient Sequence Number: 1