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U.S. Department of Health and Human Services

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

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COLOPLAST A/S TITAN TOUCH INFR ZERO ANG 22CM; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES28222400
Event Date 09/10/2019
Event Type  Injury  
Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming reports and capa review.No trends were noted.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, erosion was noted.Cross-over functioning implant.Another inflatable penile prosthesis was implanted.
 
Event Description
Clarify that it was reported that during explant, cross-over was noted, the implant was functioning.Erosion was also noted.
 
Manufacturer Narrative
This follow-up was created to clarify the original event description and conclusion of the investigation.A titan touch pump, reservoir, and two cylinders were received for evaluation.As examination of the components may not conclusively confirm or disprove the report of erosion, or crossover, quality accepts the physician's observations as to the reason for surgical intervention.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, non-conformances and capas revealed no trends for this lot.
 
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Brand Name
TITAN TOUCH INFR ZERO ANG 22CM
Type of Device
INFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA  3050
MDR Report Key9604341
MDR Text Key182570325
Report Number2125050-2020-00065
Device Sequence Number1
Product Code FHW
UDI-Device Identifier05708932539142
UDI-Public05708932539142
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 03/26/2020
1 Device 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 NumberES28222400
Device Catalogue NumberES2822
Device Lot Number5121324
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2020
Initial Date Manufacturer Received 12/18/2019
Initial Date FDA Received01/17/2020
Supplement Dates Manufacturer Received12/18/2019
Supplement Dates FDA Received03/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
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