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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC SODIUM HYALURONATE FOR INTRA-ARTICUL

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ANIKA THERAPEUTICS, INC. ORTHOVISC SODIUM HYALURONATE FOR INTRA-ARTICUL Back to Search Results
Model Number 630-254
Device Problem Break (1069)
Patient Problems Laceration(s) (1946); Injury (2348)
Event Date 08/17/2016
Event Type  Injury  
Event Description
The sales rep reported that while the pa was injecting orthovisc to the patient's knee, the syringe broke close to the plunger and cut her hand. The sales rep confirmed that a 20 gauge needle size was used. The pa needed to have stitches. Anika reached out to the patient and received the following update on august 18, 2016: called out and the patient was not there. However the receptionist sent me to her manager. He explained that the syringe was not broken before injection and the box is in perfect condition. He gave the syringe and box to the sales rep to return to us. (b)(6) was pushing down on the syringe to administer it to the patient when the upper lip of the glass syringe popped off-cutting her index and middle finger. Her index finger needed 2 stitches at urgent care. Her middle finger had a small cut that did not require stitches. She has no loss of sensation in any fingers and she told him that her pain level was 0. (b)(6) is back to work today.
 
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Brand NameORTHOVISC
Type of DeviceSODIUM HYALURONATE FOR INTRA-ARTICUL
Manufacturer (Section D)
ANIKA THERAPEUTICS, INC.
32 wiggins ave
bedford MA 01730
Manufacturer (Section G)
ANIKA THERAPEUTICS, INC.
32 wiggins ave
bedford MA 01730
Manufacturer Contact
eric blais
32 wiggins ave
bedford, MA 01730
7814579000
MDR Report Key5907060
MDR Text Key53111181
Report Number3007093114-2016-00011
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 distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician Assistant
Device Expiration Date05/31/2018
Device Model Number630-254
Device Lot NumberN160026A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/04/2016
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: 08/26/2016 Patient Sequence Number: 1
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