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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 Problem Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Date 01/21/2019
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, crossover - distal side.
 
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 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, nonconformances and capas revealed no trends for this lot.
 
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Brand Name
TITAN SCROTAL ZERO ANG 22CM
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 Key8353199
MDR Text Key136589213
Report Number2125050-2019-00118
Device Sequence Number1
Product Code FHW
UDI-Device Identifier05708932487382
UDI-Public05708932487382
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 05/24/2019
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 NumberES89222400
Device Catalogue NumberES8922
Device Lot Number6121906
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/21/2019
Initial Date FDA Received02/20/2019
Supplement Dates Manufacturer Received01/21/2019
Supplement Dates FDA Received05/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age63 YR
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