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

Model Number	ESR9222400
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Codes	Implant Pain (4561); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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
According to available information, there was difficulty and pain with cycling of this device.There was loss of rigidity due to slow fluid loss due to semipermeable nature of the reservoir.
Event or Problem Description
According to the available information this inflatable device was revised on 6/8/2021 due to leakage.Additional information received indicated difficulty cycling, pain with cycling.Loss of rigidity due to slow fluid lost due to semipermeable nature of reservoir.Device not inflating all the way.The revision surgery was without intraoperative complication and the patient was taken to the medical surgical unit in stable condition.Foley catheter was removed on pod#1, and patient was able to void spontaneously.By day of discharge, he was tolerating a regular diet without nausea/vomiting, had pain controlled with oral pain medications, and was ambulating without assistance.He was instructed on wound care, to avoid sexual intercourse and not attempt to use the prosthesis until after his postoperative visit.The sufflation was unchanged from postop settings.He received appropriate perioperative antibiotics.
Additional Manufacturer Narrative
A titan otr pump, cylinders 1 and 2 , and reservoir were received for analysis.No functional abnormalities were noted with the pump.No functional abnormalities were noted with either cylinder.No functional abnormalities were noted with the reservoir.The information received indicated the device was not inflating completely, but because no functional abnormalities were noted with the returned components, the complaint could not be confirmed 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, 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
• MDR Report Key: 12109372
• Report Number: 2125050-2021-00845
• Device Sequence Number: 11907416
• Product Code: FHW
• UDI-Device Identifier: 05708932487702
• UDI-Public: 05708932487702
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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: ESR9222400
• Device Catalogue Number: ESR922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 09/24/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR