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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN OTR INFRA ZERO ANG; INFLATABLE PENILE PROSTHESIS
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COLOPLAST A/S (2BO)TITAN OTR INFRA ZERO ANG; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ESR8162400
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Information (3190)
Date of Event 07/16/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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.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 or Problem Description
According to the available information, the tubing broke at the cylinder junction.
 
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Brand Name
(2BO)TITAN OTR INFRA ZERO ANG
Common Device Name
INFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA  3050
MDR Report Key8895243
Report Number2125050-2019-00659
Device Sequence Number1658624
Product Code FHW
UDI-Device Identifier05708932487528
UDI-Public05708932487528
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P000006
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/08/2019
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
Operator of Device Lay User/Patient
Device Model NumberESR8162400
Device Catalogue NumberESR816
Device Lot Number3470933
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/16/2019
Initial Report FDA Received Date08/14/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age72 YR
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