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

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 dated 09-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 increased pressure. All these symptoms were reported as onset of a cushing's syndrome and patient also experienced stomach pain and vitamin d increased. 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 dechallenge 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 cushing's syndrome [cushing's syndrome, steroid-induced], ([swelling of face], [swelling], [acne steroid-induced], [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], expected result/ lack of result [device ineffective], received the application on the left hip [product administered at inappropriate site], doctor placed a medicine next to the application called triancil [off label use], case narrative: initial information received on 01-sep-2020 from (b)(6) regarding an unsolicited valid serious case received from the patient. This case is linked to cases (b)(4) (multiple devices) (same patient). This case involves an unknown age female patient who did not obtain the expected result/ lack of result and received the application on the left hip, stomach pain, doctor placed a medicine next to the application called triancil, vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) and could be the onset of a cushing's syndrome, while she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one), prednisone (meticorten) her past medical treatment included on hylan g-f 20, sodium hyaluronate received on (b)(6) 2020 which she received her left knee. Her past medical history, vaccination(s) and family history were not provided. Concomitant medication included triamcinolone hexacetonide (triancil). On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, dosage, batch number, indication: unknown) for once on the left hip. (product administered at inappropriate site). On the same day, her doctor placed a medicine next to the application called triancil (off label use). On the unknown date of 2020, after 1 and a half months of taking of the product, patient did not obtain the expected result (device ineffective). As corrective of the lack of result of application of product, the patient was prescribed with prednisone (meticortem) and ketoprofen (profenid). On the unknown date in 2020, patient took prednisone (formulation, strength, dosage, indication, frequency: unknown). Patient informed that after the use of the medication he turned into a monster, because he presented with all possible side effects. On the unknown date in 2020, after unknown latency, the patient's face and body swelled absurdly, got an absurd jowl (swelling face) (swelling). The patient also presented an allergy in the middle of face. Due to allergy, patient went 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) (medically significant). In addition to these events, the patient also reports that she had stomach pain (abdominal pain upper) and the pressure increased (blood pressure increased). She was instructed by the doctor to wean the corticosteroid and continue the use of profenid. The patient related 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 150mg, two tablets a day. It was also reported that the fan and rheumatoic factor tests were negative, but vitamin d3 (hydroxy 25) was 110 which was above the desirable one that was up to 100 (reference value) (vitamin d increased). 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 would already perform the application. Final diagnosis was did not obtain the expected result/ lack of result and received the application on the left hip, vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), doctor placed a medicine next to the application called triancil, stomach pain and could be the onset of a cushing's syndrome. Action taken: not applicable for all the events with hylan g-f 20, sodium hyaluronate; not applicable for device ineffective, off label use and product administered at inappropriate site; unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) and drug withdrawn for all events with prednisone corrective treatment: not reported for all events. Outcome: recovering for could be the onset of a cushing's syndrome; 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); not applicable for rest of the events. A product technical compliant was initiated and results were pending for same.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• 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 Key: 10512783
• MDR Text Key: 213850205
• Report Number: 2246315-2020-00129
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/30/2022
• Device Lot Number: 9RSL017
• 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