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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number 9RSL017
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Hypersensitivity/Allergic reaction (1907); Swelling (2091); Therapeutic Response, Decreased (2271); No Code Available (3191)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Sanofi company comment follow-up dated 01-sep-2020: this case concerns a patient who received initial treatment with hylan g-f 20, sodium hyaluronate reported that it did not give the expected result. She later received treatment with prednisone and reported having face and body swelling, an absurd jowl, an allergy in the middle of the face which was a type of acne typically caused by corticosteroids and pressure increased. All these symptoms were reported as onset of a cushing's syndrome and patient also experienced stomach pain. Based on the temporal relationship the causal relationship of the device in the occurrence of events cannot be denied and based on the pharmacological plausibility and rechallenge results the causal relationship of prednisone in the occurrence of the events can be evidently established. However, further information regarding patient¿s current medical condition, concomitant medications and technique used while administration of injection precludes complete medical assessment of the case.
 
Event Description
Could be the onset of a cushing's syndrome [cushing's syndrome, steroid-induced] ([acne steroid-induced], [facial swelling], [swelling], [blood pressure increased]). Stomach pain [stomach pain]. Vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) [vitamin d increased]. There was no effect/not having result/not working/ did not obtain the expected result [device ineffective]. Case narrative: based on additional information received on 01-sep-2020, the case initially assessed as non-serious was updated to serious (medically significant for cushing's syndrome). This case is linked to cases, (b)(4). Initial information received from (b)(6) on 27-aug-2020 regarding an unsolicited valid serious case received from patient. This case involves an unknown age female patient who was treated with prednisone (meticorten), hylan g-f 20, sodium hyaluronate (synvisc one) and there was no effect/not having result/not working/ did not obtain the expected result, vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), could be the onset of a cushing's syndrome, stomach pain. The patient's past medical history, vaccination(s) and family history were not provided. Patient previously had treatment with hylan g-f 20, sodium hyaluronate in both shoulders 2 years ago and had quick results. On (b)(6) 2020, the patient started taking hylan g-f 20, sodium hyaluronate (strength: 6 ml) at an unknown dose once via unknown route (lot: 9rsl017) in right knee for viscosupplementation. The injection was applied in a doctor's office, they only gave the label with the number of the lot pasted. It was reported patient was not having results and the injection was not working, there was no effect (device ineffective) (onset date: 2020, latency: unknown). On the unknown date of 2020, after 1 and a half months of taking of the product, patient did not obtain the expected result. As corrective treatment the lack of result of the application of hylan g-f 20, sodium hyaluronate the patient was prescribed a corticosteroid and an anti-inflammatory, which were meticorten (prednisone) and profenid (ketoprofen). On an unknown date in 2020, the patient started using prednisone (form, route, frequency, dose and batch number: unknown). Patient informed that after the use of the medication she turned into a monster because she presented all possible side effects that included her face and body being swelled absurdly, got an absurd jowl (swelling face) (swelling) and also presented an allergy in the middle of the face. Due to this allergy, the patient had to go to general practitioner, who reported that this allergy was a type of acne typically caused by corticosteroids (acne) and could be the onset of a cushing's syndrome (cushing's syndrome; onset: 2020; latency: unknown). This event was assessed as serious due to seriousness criteria of medically significant. Patient also reported that she had stomach pain (abdominal pain upper; onset: 2020; latency: unknown) and the pressure increased (blood pressure increased; onset: 2020; latency: unknown). Doctor instructed her to wean the corticosteroid and continue the use of profenid. The patient related that the events presented to the use of corticosteroids, because when she weaned the events began to improve visibly but reported that profenid was very weak because her pains had returned. Currently the patient was only in use of profenid 150 mg, two tablets a day. It was also reported that the fan and rheumatic factor tests were negative, but vitamin d3 (hydroxy 25) was 110 which was above the desirable one that was up to 100 (reference value). The clinic informed the patient that the vitamin test might have given this alteration, because it was related to some pain of this whole situation. Patient was waiting for a period to retake vitamin d and would return to rheumatologist. The patient informed that she was currently locked and in pain. The patient did recommend synvisc one to everyone and further said that she did not want to undergo a surgery because as soon as the pain start, she already perform the application. Action taken: not applicable for all events with hylan g-f 20, sodium hyaluronate; not applicable for there was no effect/not having result/not working/ did not obtain the expected result and unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value); drug withdrawn for rest of the events with prednisone. It was not reported if the patient received a corrective treatment for all events the patient outcome is reported as not applicable for there was no effect/not having result/not working/ did not obtain the expected result; not recovered for stomach pain; unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value); recovering for rest of the events. A product technical compliant (ptc) was initiated with unknown global ptc number and local ptc number: (b)(4). Additional information was received on 01-sep-2020 from the patient. Events added for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), could be the onset of a cushing's syndrome, stomach pain. Verbatim updated to there was no effect/not having result/not working/ did not obtain the expected result. Suspect of prednisone added. Clinical course was updated. Text amended accordingly.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key10513134
MDR Text Key213066584
Report Number2246315-2020-00130
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Type of Report Initial,Followup,Followup,Followup
Report Date 11/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2022
Device Lot Number9RSL017
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/10/2020 Patient Sequence Number: 1
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