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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
Lot Number 19755
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Headache (1880); Nausea (1970); Decreased Appetite (4569)
Event Date 02/16/2022
Event Type  Injury  
Event Description
Pt received durolane injection on tuesday (b)(6) 2022.Reports symptoms started wednesday morning (b)(6) 2022.Pt reports symptoms of headache, nausea, loss of appetite, significant tiredness.Pt took benadryl as ordered by the mdo on friday.Pt reports that she felt better on saturday morning but then started to feel symptoms again later that day.Unilateral primary osteoarthritis m17.12.
 
Event Description
Pt received durolane injection on tuesday (b)(6) 2022.Reports symptoms started wednesday morning (b)(6) 2022.Pt reports symptoms of headache, nausea, loss of appetite, significant tiredness.Pt took benadryl as ordered by the mdo on friday.Pt reports that she felt better on saturday morning but then started to feel symptoms again later that day.Unilateral primary osteoarthritis m17.12.
 
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Brand Name
DUROLANE
Type of Device
ACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIOVENTUS LLC.
MDR Report Key13591844
MDR Text Key286150748
Report NumberMW5107652
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier89130202001
UDI-Public89130202001
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot Number19755
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Treatment
FLOVENT; GABAPENTIN; LIPITOR ; NORVASC; PREVACID ; SEROQUEL ; VALIUM; ZOFRAN
Patient Outcome(s) Other;
Patient Age61 YR
Patient SexFemale
Patient Weight79 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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