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

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.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM 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 Key: 5907060
• MDR Text Key: 53111181
• Report Number: 3007093114-2016-00011
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030019
• Number of Events Reported: 1
• 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 Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician Assistant
• Device Expiration Date: 05/31/2018
• Device Model Number: 630-254
• Device Lot Number: N160026A
• 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 Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2016
• 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