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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S PUMP OTR INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S PUMP OTR INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number 5177801400
Device Problem Material Too Rigid or Stiff
Event Date 05/29/2018
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. Once our evaluation is complete, a follow-up report will be submitted.

 
Event Description

According to the available information, sharp distal tips.

 
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Brand NamePUMP OTR
Type of DeviceINFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA  3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west rivier road north
minneapolis MN 55411
Manufacturer Contact
stephanie perryman
1601 west rivier road north
minneapolis , MN 55411
6124345685
MDR Report Key7653785
Report Number2125050-2018-00490
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number5177801400
Device Catalogue Number5177801400
Device LOT Number3290234
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/06/2018
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

Patient TREATMENT DATA
Date Received: 06/30/2018 Patient Sequence Number: 1
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