MAUDE Adverse Event Report: UNKNOWN ORTHOVISC INJ 15MG/ML

Device Problem Insufficient Information (3190)

Patient Problems Diarrhea (1811); Cramp(s) (2193); Constipation (3274)

Event Date 02/17/2018

Event Type  Injury  

Event Description

Pt reports cramping, constipation and then diarrhea starting after first injection about 3 weeks ago. Is the product compounded: no. Is the product over-the-counter: no. Event abated after use stopped or dose reduced: no. Event reappeared after reintroduction: doesn't apply.

• Brand Name: ORTHOVISC INJ 15MG/ML
• Type of Device: ORTHOVISC INJ 15MG/ML
• Manufacturer (Section D): UNKNOWN; 32 wiggins ave.; bedford MA 01730
• MDR Report Key: 7334324
• MDR Text Key: 102339736
• Report Number: MW5075832
• Device Sequence Number: 0
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage