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Lot Number 4RSN003
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Test Result (2695)
Event Date 11/30/2015
Event Type  Injury  
Event Description
Based on additional information received on (b)(6) 2016 from a health care professional, this case was medically confirmed. Also the case initially assessed as non-serious was upgraded to serious as an event of increased esr was added with seriousness criteria required intervention. This unsolicited device case was received from (b)(6) on (b)(6) 2015 from the patient. This case involves a (b)(6) old female patient who started treatment with synvisc and later developed increased erythrocytes sedimentation rate (esr), pain in hip going to foot/the pain that developed was different from the hip pain she experienced prior to the synvisc injection and funny voice. Medical history was significant for anxiety, voice funny and hip pain. The concomitant medications included bupropion hydrochloride (wellbutrin) for depression, esomeprazole (nexium), frovatriptan for migraine, fluticasone propionate/salmeterol xinafoate (advair) and salbutamol sulfate (ventolin). No past drug was provided. On (b)(6) 2015, the patient started treatment with intra-articular synvisc injection at a dose of 1 injection (frequency: not provided, batch/lot number: 4rsn003 and expiry date: nov-2017) for hip arthritis. On (b)(6) 2015 (about 1 week ago), 21 days after receiving treatment with synvisc, the patient developed moderate pain going from the hip to the foot. The pain was like a vibration feeling that was quite painful, and would wake her at night. It was reported that the pain was progressively getting worse and she could not cross her legs. The pain that developed was different from the hip pain she experienced prior to the synvisc injection and had started to dissipate. The patient stated that she often reacted to medications and got a funny voice (moderate) when she did react. On (b)(6) 2015, her voice was funny. On an unspecified date in 2015, patient's esr increased (moderate) and patient received unspecified antibiotics and steroids as treatment. It was reported that the events were considered related to synvisc and not to patient's preexisting condition. Action taken: unknown corrective treatment: steroids and antibiotics for voice funny and increased esr, steroids for pain in hip going to foot/the pain that developed was different from the hip pain she experienced prior to the synvisc injection outcome: unknown for increased esr and recovering for all other events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4). The production and quality control documentation for lot 4rsn003, with expiration date (11/2017) was reviewed. The investigation showed that the product met specifications. No associated non-conformances were noted. Based on the lot batch record review & lot frequency analysis for lot 4rsn003, no capa was required. Genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals. This review had not indicated any safety issue. As of (b)(6) 2016, a total of (2) complaints (including this complaint) have been reported for lot 4rsn003: (2). Adverse event reports. Genzyme biosurgery will continue to monitor complaints to determine if a capa is required. Reporter's causality: related for all events. Seriousness criteria: required intervention for all events. Additional information was received on (b)(6) 2015. Global ptc number and results were added. Text was amended accordingly. Additional information was received on (b)(6) 2016 from a health care professional. An additional event of increased esr was added along with details. Corrective treatment for all events was added. Outcome of voice funny and pain in hip going to foot/the pain that developed was different from the hip pain she experienced prior to the synvisc injection was updated from not recovered to recovering. Lot number and expiration date of synvisc was added. Seriousness criteria was added. Clinical course was updated and text was amended accordingly. Additional information was received on (b)(6) 2016. Ptc results with lot number were added and text was amended accordingly. Pharmacovigilance comment: (b)(4) company comment for follow up dated (b)(6) 2016: the follow up information received does not change the complete case assessment. (b)(4) company comment dated (b)(6) 2016: this case concerns a patient who received synvisc injection in hip and experienced the events described as voice funny and increased esr along with irradiating pain from hip to foot. As per the information provided by the treating physician the events warranted the use of medical intervention in the patient. Since, a positive relationship can be established between the occurrence of the events and the administration of the product, the causal role of product cannot be denied. However, information regarding pertinent medical history of reacting to medications and lack of detailed clinical description of the reported event, laboratory and diagnostic reports precludes a complete medical and causal assessment of this case.
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Manufacturer (Section D)
1125 pleadantview terrace
ridgefield NJ 07657
Manufacturer Contact
kristen sharma
55 corporate drive
bridgewater, NJ 08807
MDR Report Key5359628
MDR Text Key35620961
Report Number2246315-2016-00001
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Type of Report Initial
Report Date 11/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date11/01/2017
Device Lot Number4RSN003
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/12/2016 Patient Sequence Number: 1