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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S; INFLATIBLE PENILE PROSTHETIS

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COLOPLAST A/S; INFLATIBLE PENILE PROSTHETIS Back to Search Results
Model Number 5191701022
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/06/2021
Event Type  Injury  
Manufacturer Narrative
The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.
 
Event Description
According to available information, this patient experience poor filling of the cylinders of this device and a replacement procedure was indicated.Upon explant, it was noted that there was damage to the tubing near the connector between the pump and cylinder on the right side.
 
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Type of Device
INFLATIBLE PENILE PROSTHETIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA  3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
usjki jennifer kinneman
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key11282410
MDR Text Key230433958
Report Number2125050-2021-00101
Device Sequence Number1
Product Code JCW
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
P000006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
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? Yes
Device Operator No Information
Device Expiration Date09/30/2019
Device Model Number5191701022
Device Catalogue Number519170
Device Lot Number4348595
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/06/2021
Initial Date FDA Received02/04/2021
Date Device Manufactured11/06/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age45 YR
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