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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA THERAPEUTICS INC. ORTHOVISC SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION, PRODUCT CODE: MOZ

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ANIKA THERAPEUTICS INC. ORTHOVISC SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION, PRODUCT CODE: MOZ Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Fluid Discharge (2686)
Event Date 11/21/2015
Event Type  Injury  
Manufacturer Narrative
The device was not available to be returned and the lot number is unknown. Additional information is expected.
 
Event Description
Initial complaint received on (b)(6) 2015: the nurse at (b)(4) (distributor call center) called stating that the patient reported that after receiving his second orthovisc injection on (b)(6) 2015 on his right knee is experiencing excessive pain and extreme swollenness. The nurse stated that the patient was looking for medical advice so she directed him to follow up with his doctor. No medical history provided. Also, unknown when the patient received his first injection. The evaluation of this event as of this date did not indicate medical intervention and deemed not be reportable. Follow up information reported on (b)(6) 2016: the patient reported that after having his 2nd injection of orthovisc on (b)(6) 2015 his knee swelled more than he expected. He contacted his surgeon who told him it was a normal side effect and to use ice, elevate the leg, and take ibuprofen for the pain. The next day, (b)(6) , the patient reported that his knee ballooned up and he went to the emergency room. There his knee was drained of 100 cc of fluid and he was sent home. The patient was still in pain and had excessive swelling so he went into his surgeon's office on (b)(6) and had blood tests to check for lupus and lyme disease. The patient was given both an antibiotic and anti-inflammatory at that time. The patient reported the test results were negative. On (b)(6) the patient again went to the emergency room to have 100 cc of fluid drained from his knee. On (b)(6) he went back to his surgeon's office where they drained his knee again, this time the fluid was thick, yellow, and had white residue within it. The patient was admitted to the hospital and had surgery that same day for infection. During the surgery his knee was scrapped and flushed with 9 liters of saline and antibiotic. The patient was released on (b)(6) with a 28 day antibiotic iv to do at home. The patient has been on disability since (b)(6) and having physical therapy since (b)(6). The patient reported he started with 60 degree of mobility and now has 102 degrees of mobility. The evaluation based on new information received classified the event as reportable.
 
Manufacturer Narrative
The device was not available to be returned and the lot # is unknown. Additional information is expected. (b)(4). This is the electronic follow up report.
 
Event Description
Initial complaint received on (b)(6) 2015: the nurse at (b)(4) (distributor call center) called stating that the patient reported that after receiving his second orthovisc injection on (b)(6) 2015 on his right knee is experiencing excessive pain and extreme swollenness. The nurse stated that the patient was looking for medical advice so she directed him to follow up with his doctor. No medical history provided. Also, unknown when the patient received his first injection. The evaluation of this event as of this date did not indicate medical intervention and deemed not be reportable. Follow up information reported on 1/5/2016: the patient reported that after having his 2nd injection of orthovisc on (b)(6) 2015 his knee swelled more than he expected. He contacted his surgeon who told him it was a normal side effect and to use ice, elevate the leg, and take ibuprofen for the pain. The next day, (b)(6), the patient reported that his knee ballooned up and he went to the er. There his knee was drained of 100 cc of fluid and he was sent home. The patient was still in pain and had excessive swelling so he went into his surgeon's office on (b)(6) and had blood tests to check for lupus and lyme disease. The patient was given both an antibiotic and anti-inflammatory at that time. The patient reported the test results were negative. On (b)(6) the patient again went to the er to have 100 cc of fluid drained from his knee. On (b)(6) he went back to his surgeon's office where they drained his knee again, this time the fluid was thick, yellow, and had white residue within it. The patient was admitted to the hospital and had surgery that same day for infection. During the surgery his knee was scrapped and flushed with 9 liters of saline and antibiotic. The patient was released on (b)(6) with a 28 day antibiotic iv to do at home. The patient has been on disability since (b)(6) and having physical therapy since (b)(6). The patient reported he started with 60 degree of mobility and now has 102 degrees of mobility. The evaluation based on new information received classified the event as reportable. Update: on (b)(6) 2016 sent email to distributor for patient update. On (b)(6) 2016 email came in from distributor stating no patient update. On (b)(6) 2016 sent email to distributor for patient update. On (b)(6) 2016 left message for patient for an update. On (b)(6) 2016 email came in from distributor stating no patient update. On (b)(6) 2016 called out to patient and he stated his infection cleared up after taking antibiotics at home in early (b)(6) 2016. His range of motion has continued to improve and he is back to work effective (b)(6) 2016. He is done with physical therapy in the next 2 months. Several blood tests were taken and confirmed the infection has cleared up.
 
Manufacturer Narrative
Corrected data: follow up 1 had the incorrect "date of this report" please accept 3/7/2016 as the date of the follow up 1 and 2 report. Device was not available for evaluation.
 
Event Description
Initial complaint received on (b)(6) 2015: the nurse at (b)(4) (distributor call center) called stating that the patient reported that after receiving his second orthovisc injection on (b)(6) 2015 on his right knee is experiencing excessive pain and extreme swollenness. The nurse stated that the patient was looking for medical advice so she directed him to follow up with his doctor. No medical history provided. Also, unknown when the patient received his first injection. The evaluation of this event as of this date did not indicate medical intervention and deemed not be reportable. Follow up information reported on 1/5/2016: the patient reported that after having his 2nd injection of orthovisc on (b)(6) 2015 his knee swelled more than he expected. He contacted his surgeon who told him it was a normal side effect and to use ice, elevate the leg, and take ibuprofen for the pain. The next day, (b)(6), the patient reported that his knee ballooned up and he went to the er. There his knee was drained of 100 cc of fluid and he was sent home. The patient was still in pain and had excessive swelling so he went into his surgeon's office on (b)(6) and had blood tests to check for lupus and lyme disease. The patient was given both an antibiotic and anti-inflammatory at that time. The patient reported the test results were negative. On (b)(6) the patient again went to the er to have 100 cc of fluid drained from his knee. On (b)(6) he went back to his surgeon's office where they drained his knee again, this time the fluid was thick, yellow, and had white residue within it. The patient was admitted to the hospital and had surgery that same day for infection. During the surgery his knee was scrapped and flushed with 9 liters of saline and antibiotic. The patient was released on (b)(6) with a 28 day antibiotic iv to do at home. The patient has been on disability since (b)(6) and having physical therapy since (b)(6). The patient reported he started with 60 degree of mobility and now has 102 degrees of mobility. The evaluation based on new information received classified the event as reportable. Update: between (b)(6) 2016 communications were made with the distributor and there were no patient updates. The patient was also contacted and a voicemail was left. New information was received by the patient on 3/2/2016 where the patient stated his infection cleared up after taking antibiotics at home in early (b)(6) 2016. His range of motion has continued to improve and he is back to work (b)(6) 2016. He is done with physical therapy in the next 2 months. Several blood tests were taken and confirmed the infection has cleared up and is now resolved.
 
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Brand NameORTHOVISC
Type of DeviceSODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION, PRODUCT CODE: MOZ
Manufacturer (Section D)
ANIKA THERAPEUTICS INC.
32 wiggins ave
bedford MA 01730
Manufacturer Contact
eric blais
32 wiggins ave
bedford, MA 01730
7814579000
MDR Report Key5357032
MDR Text Key35623928
Report Number3007093114-2016-00001
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2016
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? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/05/2016 Patient Sequence Number: 1
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