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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW CATHETER; CATHETER, RETENTION TYPE, BALLOON
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COLOPLAST A/S X-FLOW CATHETER; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Model Number AB63221002
Device Problem Burst Container or Vessel (1074)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2020
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: october 2024.Device manufactured date: october 2019.Observation of the returned device revealed the balloon burst and part of it is missing.The balloon burst issue is known and monitored o a monthly basis.Possible root cause is a weak area in the silicone material of the balloon.
 
Event Description
According to the available information, the catheter fell off within a few hours of indwelling.A balloon burst was found.
 
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Brand Name
X-FLOW CATHETER
Type of Device
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA  3050
Manufacturer (Section G)
COLOPLAST A/S MANUFACTURING
9 avenue edmond rostand
sarlat-la-caneda 24206
FR   24206
Manufacturer Contact
usauv autumn valentine
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key11132549
MDR Text Key225565159
Report Number9610711-2021-00010
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
PMA/PMN Number
K013172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/07/2021
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 Lay User/Patient
Device Model NumberAB63221002
Device Catalogue NumberAB63221002
Device Lot Number7129999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/17/2020
Initial Date FDA Received01/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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