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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 20CM; INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 20CM; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES29202400
Device Problems Mechanical Problem (1384); Positioning Problem (3009)
Patient Problems Unspecified Infection (1930); No Information (3190)
Event Date 07/12/2019
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.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, added reservoir fluid; pump exchanged.
 
Event Description
Per additional information received: malposition of pump, infection.The device was replaced but will not be available for return.
 
Manufacturer Narrative
This follow-up mdr is created to document the additional event information, implant date, corrected device information, and the conclusion of the investigation.The device was not received for evaluation.Without the benefit of analyzing the device, quality cannot confirm any observations or comment on the condition of the product.If the device becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.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.
 
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Brand Name
TITAN TOUCH SCRO ZERO ANG 20CM
Type of Device
INFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA  3050
MDR Report Key8880323
MDR Text Key153872391
Report Number2125050-2019-00645
Device Sequence Number1
Product Code FHW
UDI-Device Identifier05708932533966
UDI-Public05708932533966
Combination Product (y/n)N
PMA/PMN Number
P000006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberES29202400
Device Catalogue NumberES2920
Device Lot Number6467934
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/12/2019
Initial Date FDA Received08/09/2019
Supplement Dates Manufacturer Received07/12/2019
Supplement Dates FDA Received10/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age71 YR
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