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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 18CM; INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 18CM; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES29182400
Device Problems Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979); Migration (4003)
Patient Problem Erosion (1750)
Event Date 01/15/2019
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, erosion/ extrusion - crossover, near extrusion.
 
Manufacturer Narrative
This follow-up mdr is created to document the conclusion of the evaluation.The device was not received for evaluation.As examination of the device may not conclusively confirm or disprove the report of erosion/ extrusion and crossover, near extrusion 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 revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.
 
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Brand Name
TITAN TOUCH SCRO ZERO ANG 18CM
Type of Device
INFLATABLE 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 Key8339639
MDR Text Key136156618
Report Number2125050-2019-00102
Device Sequence Number1
Product Code FHW
UDI-Device Identifier05708932539180
UDI-Public05708932539180
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 05/08/2019
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 NumberES29182400
Device Catalogue NumberES2918
Device Lot Number4904035
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/15/2019
Initial Date FDA Received02/14/2019
Supplement Dates Manufacturer Received01/15/2019
Supplement Dates FDA Received05/10/2019
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 Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age73 YR
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