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

Model Number	5177801400
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A titan was indicated as the penile prosthesis removed.No information regarding lot number was provided.The item number above was entered to record that a titan product had been explanted.Should additional information be received, the file will be updated.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Event or Problem Description
As reported to coloplast, though not verified the device ¿went flat" and leaks.The device was removed/replaced.
Additional Manufacturer Narrative
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.
Event or Problem Description
This follow-up mdr is created to document the additional event information received for record #610384.According to the available information the inflatable penile prosthesis was implanted on (b)(6) 2012 removed and replaced on (b)(6) 2020 as the device ¿went flat¿, leaks.Attempts to obtain additional information were unsuccessful.The device was not received for evaluation.Without the benefit of analyzing the device, quality cannot confirm any observations or comment on the condition of the product.If the device becomes available, or additional information is received, the complaint will be re-evaluated according 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, non-conformances and capas revealed no trends for this lot.

• Brand Name: TITAN OTR
• Common Device Name: INFLATABLE PENILE PROTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10584312
• Report Number: 2125050-2020-00880
• Device Sequence Number: 16901242
• Product Code: FHW
• UDI-Device Identifier: 05708932319744
• UDI-Public: 05708932319744
• Combination Product (Y/N): N
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: 5177801400
• Device Catalogue Number: 517780
• Device Lot Number: 3224707
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 10/29/2020
• Patient Sequence Number: 1
• Patient Age: 80 YR