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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN; INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES88202400
Device Problem Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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 information, the patient with this device required a repositioning of the pump.No adverse patient effects were reported.
 
Event Description
Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.
 
Manufacturer Narrative
According to the available information the titan was implanted on (b)(6) 2020 and revised on (b)(6) 2021 to reposition the pump.The device was not returned for evaluation.However, because examination of the returned components may not conclusively confirm or disprove the report of repositioning, quality accepts the physician¿s observations of such as 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
Type of Device
INFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA  3050
MDR Report Key12000239
MDR Text Key256229454
Report Number2125050-2021-00753
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 health professional
Type of Report Initial,Followup
Report Date 08/19/2021
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? Yes
Device Operator Lay User/Patient
Device Model NumberES88202400
Device Catalogue NumberES8820
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/20/2021
Initial Date FDA Received06/15/2021
Supplement Dates Manufacturer Received05/20/2021
Supplement Dates FDA Received08/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age54 YR
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