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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S ALPHA I 18CM SCROTAL INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S ALPHA I 18CM SCROTAL INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number 5187401000
Device Problems Inflation Problem; Excess Flow or Over-Infusion; Leak / Splash
Event Date 08/12/2019
Event Type  Injury  
Manufacturer Narrative

The device has been received at coloplast; however the evaluation is not yet complete. 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, there was auto inflation and leak in the tubing. Additional information received stated the break was near the reservoir, the tubing was cut, the the reservoir was left in.

 
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Brand NameALPHA I 18CM SCROTAL
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 river road north
minneapolis , MN 55411
6123578517
MDR Report Key8983832
Report Number2125050-2019-00743
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial,Followup
Report Date 12/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number5187401000
Device Catalogue Number518740
Device LOT Number763977
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/16/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2019
Was Device Evaluated By Manufacturer? Yes
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: 09/10/2019 Patient Sequence Number: 1
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