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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC TITAN TOUCH; INFLATABLE PENILE PROTHESIS

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COLOPLAST MANUFACTURING US, LLC TITAN TOUCH; INFLATABLE PENILE PROTHESIS Back to Search Results
Model Number ES29182400
Device Problem Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
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 Description
According to the available information, though not verified, a patient is having issues deflating his implant.According to the physician the pump is positioned high in the scrotum and difficult to access.Additional info.Per tm on 12/28: " i have not received any update.No revision surgery is scheduled.".
 
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Brand Name
TITAN TOUCH
Type of Device
INFLATABLE PENILE PROTHESIS
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
usrll rachel lloyd
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key11175693
MDR Text Key227036109
Report Number2125050-2021-00068
Device Sequence Number1
Product Code FHW
UDI-Device Identifier05708932539180
UDI-Public05708932539180
Combination Product (y/n)N
PMA/PMN Number
P000006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 01/15/2021
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
Device Operator Health Professional
Device Model NumberES29182400
Device Catalogue NumberES2918
Device Lot Number7525947
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/23/2020
Initial Date FDA Received01/14/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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