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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEDEC-MEIJI FARMA GENVISC 850 ACID, HYALURONIC, INTRAARTICULAR

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TEDEC-MEIJI FARMA GENVISC 850 ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number K-1
Device Problem No Apparent Adverse Event (3189)
Patient Problems Pain (1994); Arthralgia (2355)
Event Date 06/23/2017
Event Type  Injury  
Event Description
Patient reported to orthogenrx genvisc 850 call center the first 3 injections of genvisc 850 went well. After the 4th injection of genvisc 850 his knee felt worse and he had fluid drained. When he walks the knee hurts. The bone feels broken inside. When bending the knee a sound like "ke ke ke" occurs, likely crepitus. This ae assessor has placed multiple calls to the pt. And the pt. Has not answered nor returned the calls. It is not possible to assess contributory factors without the pts. Medical history, pain level and diagnostics if any were performed. The genvisc 850 cannot be ruled out as a contributing factor. If the pt. Returns the calls, the case will be reopened for further investigation. Based upon the information provided no remedial action is required. This case is being closed as a serious because the pt. Reported an effusion with significant pain after the 4th genvisc850 injection. The case is limited in investigation and will be closed without further follow-up from the ae assessor.
 
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Brand NameGENVISC 850
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
TEDEC-MEIJI FARMA
ctra. m-300, km 30, 500
alcala de henares (madrid), 28802
SP 28802
Manufacturer (Section G)
TEDEC-MEIJI FARMA
ctra. m-300, km 30,500
alcala de henares, madrid 28802
SP 28802
Manufacturer Contact
celia vazquez lopez
ctra. m-300, km 30, 500
alcala de henares, madrid 28802
SP   28802
MDR Report Key6742620
MDR Text Key80988218
Report Number3003184440-2017-00012
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2019
Device Lot NumberK-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date06/23/2017
Event Location No Information
Date Report to Manufacturer06/23/2017
Date Manufacturer Received06/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/25/2017 Patient Sequence Number: 1
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