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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. / SEIKAGAKU CORPORATION, TAKAHAGI PLANT GEL-ONE CROSS LINKED HYALURONATE HYALURONIC ACID

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ZIMMER, INC. / SEIKAGAKU CORPORATION, TAKAHAGI PLANT GEL-ONE CROSS LINKED HYALURONATE HYALURONIC ACID Back to Search Results
Lot Number 0019G08G
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dyspnea (1816); Fainting (1847); Dizziness (2194); Diminished Pulse Pressure (2606)
Event Date 10/23/2019
Event Type  Injury  
Event Description
I went to my rheumatologist to have an injection in my knee (gel- one ) since this was my third injection in 2 years, so i knew what to expect. My doctor first cleaned the area with alcohol and then she sprayed a topical numbing spray (gebaurer ethyl chloride). My doctor then injected the gel-one in my knee. My doctor asked me several times if i was ok since it was harder for the medicine to injected this time. After the full injection was administered, i started feeling light-headed, seeing stars and was really faint and then my throat started feeling weird, i started wheezing and having a problem breathing. My pulse was very low. My doctor called 911 she administered benadryl by injection and also, a steroid by injection and nothing was helping so they ended up using my epi-pen (i am allergic to bees). One i was stabled i was taken to mary washington healthcare for observation. I did see an allergist who kept the gel-one packaging but i do have the lot number.
 
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Brand NameGEL-ONE CROSS LINKED HYALURONATE
Type of DeviceHYALURONIC ACID
Manufacturer (Section D)
ZIMMER, INC. / SEIKAGAKU CORPORATION, TAKAHAGI PLANT
MDR Report Key9348810
MDR Text Key167319544
Report NumberMW5091186
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number0019G08G
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 11/19/2019 Patient Sequence Number: 1
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