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U.S. Department of Health and Human Services

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

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COLOPLAST A/S PUMP INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number 5177701400
Device Problem Migration or Expulsion of Device
Event Date 02/07/2019
Event Type  Injury  
Manufacturer Narrative

A review of the complaint history database revealed no trends for this lot. Review of nonconforming reports revealed no nonconformances for this lot. No capas are associated with this lot. 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, crossover distal.

 
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Brand NamePUMP
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
sarah o'gara
1601 west rivier road north
minneapolis , MN 55411
6123578517
MDR Report Key8505650
Report Number2125050-2019-00257
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Type of Report Initial
Report Date 04/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number5177701400
Device Catalogue Number517770
Device LOT Number6282077
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2019
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 Unkown

Patient TREATMENT DATA
Date Received: 04/11/2019 Patient Sequence Number: 1
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