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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 Problems Migration or Expulsion of Device ; Inadequacy of Device Shape and/or Size
Event Date 01/28/2019
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, infection. Pump migrated up and pump flipped 180 degrees.

 
Manufacturer Narrative

This follow-up mdr is created to document the device received and updated event information. A review of the device history record confirmed the devices from this lot met all specifications prior to release. A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

 
Event Description

Additional information received, additional clarification was received from the physician on the reported event. According to the physician the pump flipped 180 degrees up to the penile scrotal junction. Patient turned out not to be infected after culture, but appeared to be infected during the explant surgery so a wash out was done. The physician still suspects there was an infection in the scrotum and left corpora. The patient was on antibiotics which the physician things is why the culture came back negative. Both corporotomies were open and hadn't healed.

 
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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 Key8368656
Report Number2125050-2019-00141
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2019
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 Number6450370
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/27/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2019
Was Device Evaluated By Manufacturer? No
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: 02/25/2019 Patient Sequence Number: 1
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