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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL RESIST 20; INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN SCROTAL RESIST 20; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number QS89201000
Device Problems Inflation Problem (1310); Leak/Splash (1354)
Patient Problem No Information (3190)
Event Date 11/22/2019
Event Type  Injury  
Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa review.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 Description
According to the available information, the device was explanted due to a leak in reservoir tubing to pump.Per the report, it took 15 pumps to fill 47 ml.Another inflatable device was implanted.
 
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Brand Name
TITAN SCROTAL RESIST 20
Type of Device
INFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA  3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
stephanie perryman
1601 west river road north
minneapolis, MN 55411
6124345685
MDR Report Key9535728
MDR Text Key173228465
Report Number2125050-2019-01173
Device Sequence Number1
Product Code FHW
Combination Product (y/n)N
PMA/PMN Number
P000006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 12/26/2019
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? No
Device Operator Lay User/Patient
Device Model NumberQS89201000
Device Catalogue NumberQS8920
Device Lot Number5542673
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/04/2019
Initial Date FDA Received12/31/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age65 YR
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