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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BSN-JOBST GMBH MEDICAL COMPRESSION HOSE; STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)
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BSN-JOBST GMBH MEDICAL COMPRESSION HOSE; STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS) Back to Search Results
Device Problems Product Quality Problem (1506); Material Integrity Problem (2978)
Patient Problems Edema (1820); Discomfort (2330)
Event Date 05/24/2020
Event Type  Injury  
Event Description
Looks like might cause deep vein thrombosis.The jobst medical compression hose elastic fabric doesn't compare with the u.S.Made before 2018.The hose have been outsourced to (b)(6).The fabric is weak and lets the blood stagnate at the ankles, causing awful and very uncomfortable swelling / ligation making 2-3 white rings around ankles.This could cause a blood clot.The hose had been recommended way before 2018 by a doctor, as i was getting spider veins and tired legs.This outsourcing is bad for our economy and bad for health.These hose are not inexpensive either, almost (b)(6).Incident date: (b)(6) 2020.Purchase date: (b)(6) 2020.(b)(4).Fda safety report id# (b)(4).
 
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Brand Name
MEDICAL COMPRESSION HOSE
Type of Device
STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)
Manufacturer (Section D)
BSN-JOBST GMBH
MDR Report Key10217714
MDR Text Key197372549
Report NumberMW5095305
Device Sequence Number1
Product Code DWL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/26/2020
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 No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/30/2020
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age79 YR
Patient Weight51
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