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

Model Number	EN29112400
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
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, implant was undersized and crossed over distally.The patient only had one cylinder implanted.The original reservoir was saved.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

• Brand Name: TITAN TOUCH
• Common Device Name: INFLATABLE PENILE PROTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10947766
• Report Number: 2125050-2020-01207
• Device Sequence Number: 11565992
• Product Code: FHW
• UDI-Device Identifier: 05708932539081
• UDI-Public: 05708932539081
• Combination Product (Y/N): N
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2020

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: EN29112400
• Device Catalogue Number: EN2911
• Device Lot Number: 4062298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/04/2020
• Patient Sequence Number: 1
• Patient Age: 79 YR