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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 Name
GEL-ONE CROSS LINKED HYALURONATE
Type of Device
HYALURONIC ACID
Manufacturer (Section D)
ZIMMER, INC. / SEIKAGAKU CORPORATION, TAKAHAGI PLANT
MDR Report Key9348810
MDR Text Key167319544
Report NumberMW5091186
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier87541030091
UDI-Public87541030091
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 No Information
Device Lot Number0019G08G
Was Device Available for Evaluation? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age54 YR
Patient Weight81
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