MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC (SYNVISC); INTRA-ARTICULAR HYALURONIC ACID

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Type  Injury  

Event Description

This unsolicited case from (b)(6) was received on 05-mar-2018 from the health care professional (pharmacist).This case concerns a male patient with unspecified age who received treatment with synvisc injection and after 2 weeks the patient experienced bad rash and blister like rash/ rash started at his legs then spread to his whole body.No relevant medical history, past drugs and concurrent condition was reported.Patient had no known allergies.The patient was taking paracetamol (panadol osteo) and duloxetine hydrochloride (cymbalta) long term.On an unknown date, the patient received treatment with intra-articular synvisc injection (dose, frequency, indication, lot number and expiration date: not reported).On an unknown date, 2 weeks after receiving the injection, the patient developed a bad rash and a blister-like rash.The rash started at his legs then spread to his whole body.Eighteen (18) months later the patient still experienced the rash with attacks of it 'now and then.Patient was using unspecified corticosteroids at treatment.Action taken: unknown.Corrective treatment: unspecified corticosteroid.Outcome: unknown.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criterion: required intervention.No further information was provided.Consent to contact for follow-up was given.Pharmacovigilance comment: sanofi company comment dated 6-mar-2018: this case concerns a patient who received treatment with synvisc and after two weeks experienced rash.Since a significant temporal relationship can be established the causal role of suspect product cannot be denied in occurrence of the event.However, due to lack of information regarding medical history, concurrent condition and past drugs complete medical assessment of the case is difficult.

Event Description

This unsolicited case from australia was received from the health care professional (pharmacist).This case concerns a male patient with unspecified age who received treatment with synvisc injection and after 2 weeks the patient experienced bad rash and blister like rash/ rash started at his legs then spread to his whole body.No relevant medical history, past drugs and concurrent condition was reported.Patient had no known allergies.The patient was taking paracetamol (panadol osteo) and duloxetine hydrochloride (cymbalta) long term.On an unknown date, the patient received treatment with intra-articular synvisc injection (dose, frequency, indication, lot number and expiration date: not reported).On an unknown date, 2 weeks after receiving the injection, the patient developed a bad rash and a blister-like rash.The rash started at his legs then spread to his whole body.18 months later the patient still experienced the rash with attacks of it 'now and then.Patient was using unspecified corticosteroids at treatment.Action taken: unknown.Corrective treatment: unspecified corticosteroid.Outcome: unknown.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criterion: required intervention.No further information was provided.Consent to contact for follow-up was given.Pharmacovigilance comment: sanofi company comment dated 6-mar-2018: this case concerns a patient who received treatment with synvisc and after two weeks experienced rash.Since a significant temporal relationship can be established the causal role of suspect product cannot be denied in occurrence of the event.However, due to lack of information regarding medical history, concurrent condition and past drugs complete medical assessment of the case is difficult.

• Brand Name: SYNVISC (SYNVISC)
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• MDR Report Key: 7334183
• MDR Text Key: 102222145
• Report Number: 2246315-2018-00379
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 03/21/2018
• Patient Sequence Number: 1
• Treatment: CYMBALTA(CON.).; CYMBALTA(CON.).; PANADOL OSTEO(CON.).; PANADOL OSTEO(CON.).; CYMBALTA(CON.); PANADOL OSTEO(CON.)
• Patient Outcome(s): Required Intervention