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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN NARROW SCROT 16CM; INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN NARROW SCROT 16CM; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number QN89161400
Device Problems Material Frayed (1262); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/29/2017
Event Type  Injury  
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 of 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 pump tubing frayed and leaks.
 
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Brand Name
TITAN NARROW SCROT 16CM
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
christine buckvold
1601 west river road north
minneapolis, MN 55411
6123024982
MDR Report Key6882873
MDR Text Key87156804
Report Number2125050-2017-00437
Device Sequence Number1
Product Code FHW
UDI-Device Identifier05708932323604
UDI-Public05708932323604
Combination Product (y/n)N
PMA/PMN Number
P000006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial
Report Date 09/19/2017
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 NumberQN89161400
Device Catalogue NumberQN89161400
Device Lot Number5491300
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/07/2017
Initial Date FDA Received09/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age52 YR
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