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

Model Number	ESR9222400
Medical Device Problem Codes	Failure to Pump (1502); Insufficient Device Problem Information (3190); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.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.Lot number: 3485937.
Event or Problem Description
According to the available information, the pump was damaged.The pump was replaced.
Event or Problem Description
Additional information received further reported that the pump would not pump; it was extremely hard and they could not get it going.
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.
Additional Manufacturer Narrative
A titan touch pump was received for evaluation.No functional abnormalities were noted with the pump.The information received indicated the pump was difficult to pump, 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: 11686204
• Report Number: 2125050-2021-00380
• Device Sequence Number: 14186914
• Product Code: FHW
• UDI-Device Identifier: 05708932487702
• UDI-Public: 05708932487702
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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,Followup
• Report Date (Section B): 08/03/2021

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: Lay User/Patient
• Device Model Number: ESR9222400
• Device Catalogue Number: ESR922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 04/21/2021; 06/18/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 07/29/2021; 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR