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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL SILICONE CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

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COLOPLAST A/S FOLYSIL SILICONE CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL Back to Search Results
Model Number AA61161002
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2022
Event Type  Injury  
Event Description
According to available information, this device required replacement due to a break.The patient was hospitalized in intensive care for second degree burns and had a device placed.The patient fell out of bed and ripped the device so that it was cut into two pieces.The balloon was removed from the bladder by cystoscopy and forceps.
 
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.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.
 
Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't find any other complaints with the same lot number 8350399.Checking the quality databases didn't reveal any anomaly in connection with the described defect.We received one used sample.After disinfection sample was observed, tip's part was missing, it seems to be torn probably due to an excess of force.We estimate the incident of foley catheter in-situ rupture is more in favor of a misuse related to the patient handling in a context of falling from the bed.The risk identification is extract criq247 with risk 11402.
 
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Brand Name
FOLYSIL SILICONE CATHETER
Type of Device
INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
Manufacturer (Section D)
COLOPLAST A/S
1 holtedam humlebaek, dk 3050
humlebaek 3050
DA  3050
Manufacturer (Section G)
COLOPLAST A/S MANUFACTURING
9 avenue edmond rostand
sarlat-la-caneda 24206
FR   24206
Manufacturer Contact
usbes brian schmidt
1601 west river road n
minneapolis, MN 55411
8007880293
MDR Report Key15699447
MDR Text Key302697206
Report Number9610711-2022-00091
Device Sequence Number1
Product Code EZL
UDI-Device Identifier03600040127490
UDI-Public03600040127490
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K013174
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,Followup
Report Date 07/05/2024
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 Health Professional
Device Model NumberAA61161002
Device Catalogue NumberAA6116
Device Lot Number8350399_AA61161002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/10/2022
Initial Date FDA Received10/31/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
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