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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S PORGES COLOPLAST; CATHETER, RETENTION TYPE, BALLOON
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COLOPLAST A/S PORGES COLOPLAST; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Model Number AA6106
Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/21/2021
Event Type  malfunction  
Event Description
6 fr foley placed without difficulty or resistance.Balloon inflated with 1.5ml sterile water per manufacturer instructions.Collection bag attached.Foley fell out of patient.Upon closer inspection, tip of foley no longer intact.Urology consulted and performed bladder irrigation and cystoscopy.No evidence of foley remnant.Tip of foley broke.A second 6fr foley was placed by urology without difficulty.Reassess manufacturer and policy on balloon inflation.Closer inspection of balloon.
 
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Brand Name
PORGES COLOPLAST
Type of Device
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
COLOPLAST A/S
1601 west river road north
minneapolis MN 55411
MDR Report Key12237944
MDR Text Key263846325
Report Number12237944
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAA6106
Device Catalogue NumberAA6106
Device Lot Number7761572
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/26/2021
Event Location Hospital
Date Report to Manufacturer07/28/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age60 DA
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