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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IBSA FARMACEUTICI ITALIA SRL GELSYN HYALURONIC ACID

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IBSA FARMACEUTICI ITALIA SRL GELSYN HYALURONIC ACID Back to Search Results
Model Number N/A
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Bacterial Infection (1735); Pain (1994); Swelling/ Edema (4577)
Event Date 05/06/2022
Event Type  Injury  
Event Description
As reported by the patient, 4 days after receiving a gelsyn injection the patient was hospitalized for an infection and treated with iv antibiotics. The patient had two previous gelsyn injections with no adverse events reported. After receiving the third injection the patient reported swelling and pain immediately following the injection. The patient indicated they were unable to walk or raise their left leg. Patient has severe osteoathritis in their left knee. The patient was released from the hospital in stable condition and prescribed antibiotics for 6 weeks.
 
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Brand NameGELSYN
Type of DeviceHYALURONIC ACID
Manufacturer (Section D)
IBSA FARMACEUTICI ITALIA SRL
via martiri di cefalonia
lodi, 2-269 00
IT 2-26900
MDR Report Key14800611
MDR Text Key295059016
Report Number3009595577-2022-00001
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier08033638951057
UDI-Public(01)08033638951057(10)2109079(17)240930
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/24/2022,07/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberGS3111
Device Lot Number2109079
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2022
Event Location Nursing Home
Date Report to Manufacturer05/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/24/2022 Patient Sequence Number: 1
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