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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL ZERO ANG 22CM INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN SCROTAL ZERO ANG 22CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES89222400
Device Problems Inflation Problem; Free or Unrestricted Flow; Pumping Problem
Event Type  Injury  
Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming reports and capa review. No trends were noted. 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, after implant the patient experienced some auto inflation. The coloplast representative who attended the implant surgery stated there were no issues noted during the surgery. Per patient, after leaving the hospital and picking up prescriptions, four hours into his drive home, he began "crashing. " the patient went to the hospital and had a cat scan, and an ilius was noted. While in the hospital the patient stated his penile implant auto deflated. The patient complained of the pump being hard and that his scrotum was tender. The patient noted being able to feel the tubing and difficulty with pumping. He stated he pumped the implant 12 times, which produced minimal movement. The device remains implanted.

 
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Brand NameTITAN SCROTAL ZERO ANG 22CM
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 river road north
minneapolis MN 55411
Manufacturer Contact
sarah o'gara
1601 west river road north
minneapolis , MN 55411
6123578517
MDR Report Key9351325
Report Number2125050-2019-01042
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial
Report Date 11/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberES89222400
Device Catalogue NumberES8922
Device LOT Number6891549
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2019
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: 11/20/2019 Patient Sequence Number: 1
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