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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOVENTUS LLC DUROLANE ; ACID, HYALURONIC, INTRAARTICULAR

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BIOVENTUS LLC DUROLANE ; ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Joint Swelling (2356); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
Event Date 01/10/2020
Event Type  Injury  
Event Description
Severe pain, leg swelling.Durolane injection given bilateral knees on (b)(6) 2020.Severe pain and swelling in quadriceps muscle resulted.Still severe pain 5 days later.Was unable to walk, get into or out of bed, get on or off toilet.Tried ice, tylenol, naproxen without relief.Pain was so severe i could not sleep past 2 am.It is not infected.There is currently no caller or erythema.I had durolane injections in the past with only a few hours of discomfort afterward.This was a whole different animal.I am now day 5 after injections and l knee is almost back to baseline, but right still with significant pain and bulge in quadriceps for 14 cm above patella.I am a retired physician and realize this is significant enough that it should be reported.(b)(6) administered the product and would have batch number if needed.
 
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Brand Name
DUROLANE
Type of Device
ACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIOVENTUS LLC
MDR Report Key9729095
MDR Text Key180621493
Report NumberMW5093091
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 02/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age68 YR
Patient Weight101
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