• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ANIKA THERAPEUTICS, INC. ORTHOVISC SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION Back to Search Results
Model Number N/A
Device Problems Device Operates Differently Than Expected (2913); No Apparent Adverse Event (3189)
Patient Problem Fall (1848)
Event Date 07/29/2016
Event Type  Injury  
Manufacturer Narrative
The lot met the specifications for release. This report was originally filed on 03feb2017 on the test server. The account was approved and moved to the production server on 7august2017. I was informed to resubmit all previous files to the production server. Production account approval help desk ticket # (b)(4). Notification of moving files to production account help desk ticket # (b)(4).
 
Event Description
Event description as received on (b)(6) 2016: "faxed paper work from the pap group stating it started on the right side first injected 2cc of orthovisc batch number n150087a, 01/18 expiration with 2cc of 1% lidocaine without epinephrine or preservative and 40 mg of preservative free kenalog. I prepped with alcohol and chloraprep. I injected without difficulty. I did get verbal consent and the patient identified the right side as the correct side. I then went to the left side third injection 2cc of orthovisc batch number n150087a, 01/18 expiration and with 2cc of 1% lidocaine without epinephrine or preservatives and 40 mg of preservative free kenalog. I prepped with alcohol and chloraprep. I injected with following ethyl chloride anesthesia into the glenohumeral joint without difficulty. This is the third injection in her left shoulder so we did two injections one in the right one in the left both third injections. She tolerated the injections sent her on the way talked about surgery. She did fall. She got x-rays at (b)(6) two views right shoulder. She has pretty severe medialization multiple vascular clips consisting with lymph node dissection and a small chip medially inferior glenoid. I do believe that her humorous is impinging on her glenoid inferiorly because she has a medial wear and probably cracked that. Otherwise, i did not see any fracture that were obvious my thoughts even doing a shoulder replacement on her. It is going to be a challenge because she has such medialization. She will need a bone increased offset implant. I will see her back as needed. ".
 
Manufacturer Narrative
(b)(4).
 
Event Description
Event description as received on (b)(6) 2016: "faxed paper work from the pap group stating it started on the right side first injected 2cc of orthovisc batch number n150087a, 01/18 expiration with 2cc of 1% lidocaine without epinephrine or preservative and 40 mg of preservative free kenalog. I prepped with alcohol and chloraprep. I injected without difficulty. I did get verbal consent and the patient identified the right side as the correct side. I then went to the left side third injection 2cc of orthovisc batch number n150087a, 01/18 expiration and with 2cc of 1% lidocaine without epinephrine or preservatives and 40 mg of preservative free kenalog. I prepped with alcohol and chloraprep. I injected with following ethyl chloride anesthesia into the glenohumeral joint without difficulty. This is the third injection in her left shoulder so we did two injections one in the right one in the left both third injections. She tolerated the injections sent her on the way talked about surgery. She did fall. She got x-rays at (b)(6) two views right shoulder. She has pretty severe medialization multiple vascular clips consisting with lymph node dissection and a small chip medially inferior glenoid. I do believe that her humerous is impinging on her glenoid inferiorly because she has a medial wear and probably cracked that. Otherwise, i did not see any fracture that were obvious my thoughts even doing a shoulder replacement on her. It is going to be a challenge because she has such medialization. She will need a bone increased offset implant. I will see her back as needed. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameORTHOVISC
Type of DeviceSODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
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
armando botelho
32 wiggins ave
bedford, MA 01730
7814579000
MDR Report Key6786460
MDR Text Key212470883
Report Number3007093114-2017-00002
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
090031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 08/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2018
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN150087A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/15/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/07/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/10/2017 Patient Sequence Number: 1
-
-