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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENEZYME SYNVISC
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GENEZYME SYNVISC Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Pain (1994); Burning Sensation (2146); Urticaria (2278); Inadequate Pain Relief (2388)
Event Date 03/31/2017
Event Type  Injury  
Event Description
I received a synvisc injection into my right knee for osteoarthritis pain.Later i developed extreme itching from head to toe, all over my body, hives, bumps, burning and pain in my right knee.I immediately started benadryl, 12.5 mg bid but it did not work! after finally see my orthopaedic after 4 days, he put me on a metro dos pak, 4 mg.I am still suffering with severe burning and pain after receiving just 1 synovis injection.I am not allergic to poultry or eggs.Is the product compounded: yes.Did the problem stop after the person reduced the dose or stopped taking or using the product: no.Did the problem return if the person starting taking or using the product again: yes.Do you still have the product in case we need to evaluate it: no.Osteoarthritis.
 
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Brand Name
SYNVISC
Type of Device
SYNVISC
Manufacturer (Section D)
GENEZYME
MDR Report Key6480434
MDR Text Key72567897
Report NumberMW5069014
Device Sequence Number1
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date03/31/2017
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
B12 1000 MCH INJECTION.; CELEBREX 200 MG; IMITREX 100 MG; KLONOPIN 1 MG; OTC MEDS: D3 1000 MCG.; PAXIL 30 MG; PROAIR INHALER; PROTONIX 40 MG; RX MEDS: SOMA 350 MG
Patient Age54 YR
Patient Weight67
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