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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEIKAGAKU CORPORATION SUPARTZ FX; ACID, HYALURONIC, INTRAARTICULAR

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SEIKAGAKU CORPORATION SUPARTZ FX; ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Model Number 89130-4444-01
Device Problem Insufficient Information (3190)
Patient Problem Bacterial Infection (1735)
Event Date 11/08/2017
Event Type  Injury  
Manufacturer Narrative
This is a definitive report.This case is listed in maude database of the fda site as mw5074735.No contact information was available.Company comment: the positive staph infection was considered to be developed due to the injection procedure or the patient's condition rather than the product quality issue, since all of product batches were assured to pass with the release test including the sterility test before the product release.The causality assessment was therefore determined "not related".(b)(4).
 
Event Description
On (b)(6) 2017 - a patient received a series of 5 supartz injections to the left knee for arthritis, one shot per week.The patient had received these shots prior to this episode with no problem.On (b)(6) 2017 - a positive staph infection occurred within 36 hrs after the 5th injection which was diagnosed with emergency surgery required.I.V.Meds for 5 weeks were administered.On (b)(6) 2018 -the patient stated the blood tests still showed abnormalities and the patient still has been unable to bare weight or walk without cane/crutches.The patient stated the pain was unbearable and the patient have never experienced this type of life changing event ever.The patient felt the recovery has been a nightmare and a very slow process.
 
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Brand Name
SUPARTZ FX
Type of Device
ACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORPORATION
marunouchi center building
6-1, marunouchi 1-chome
chiyoda-ku, tokyo 100-0 005
JA  100-0005
Manufacturer (Section G)
SEIKAGAKU CORPORATION - TAKAHAGI PLANT
258-5, aza-matsukubo,
oaza-akahama
takahagi-shi, ibaraki 318-0 001
JA   318-0001
Manufacturer Contact
pharmacovigilance dept.
marunouchi center building
6-1, marunouchi 1-chome
chiyoda-ku, tokyo 100-0-005
JA   100-0005
MDR Report Key7327240
MDR Text Key101999666
Report Number9612392-2018-00003
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P980044
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 01/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number89130-4444-01
Device Catalogue Number7156-4444
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/22/2018
Event Location Home
Initial Date Manufacturer Received 02/21/2018
Initial Date FDA Received03/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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