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

Model Number	ESR8162400
Medical Device Problem Codes	Fracture (1260); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to available information, this device required replacement due to tubing extruding from the scrotum.No other adverse patient effects were reported.
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.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
Additional information received further reported that there was a break in the clear tubing.
Additional Manufacturer Narrative
D4 lot number: 3524768.Correction: the d4 item number and unique identifier were previously reported as item number es28202400 and udi (b)(4); however, additional review determined the item number and udi were unknown at that time.The item number and udi have been corrected based on additional information received.
Additional Manufacturer Narrative
Titan otr pump, cylinders 1 and 2, and reservoir were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.Partial separations, surrounded by abrasion, were noted on the longer exhaust tube of the pump.These were not sites of leakage.A separation, surrounded by abrasion, was noted on the longer exhaust tube of the pump.This is a site of leakage.Abrasion was noted on the exhaust tube of cylinder 1.Partial separations, surrounded by abrasion, were noted on the exhaust tube of cylinder 1.This was not a site of leakage.No functional abnormalities were noted with cylinder 1 or cylinder 2.Abrasion was noted on the inlet tube of the reservoir.Partial separations, surrounded by abrasion, were noted on the inlet tube of the reservoir.This is not a site of leakage.No functional abnormalities were noted with the reservoir.Based on examination of the returned product, it was concluded that the abrasion marks noted on both exhaust tubes and inlet tube of the pump matched in such a way to conclude that they had overlapped and abraded against one another while in-vivo enough to cause a separation of the longer exhaust tubing.A separation of this type could then allow the loss of fluid, making the device inoperable.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.

• Brand Name: TITAN OTR
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13690208
• Report Number: 2125050-2022-00206
• Device Sequence Number: 1945057
• Product Code: FHW
• UDI-Device Identifier: 05708932487528
• UDI-Public: 05708932487528
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: ESR8162400
• Device Catalogue Number: ES2820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 03/21/2022; 05/27/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 03/23/2022; 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male