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

Lot Number UNKNOWN

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

Patient Problems Autoimmune Disorder (1732); Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6) comment dated 09-nov-2022: this case involves a 78 years old female patient who reported an autoimmune response, unexplained body rash about 8 months ago after injection lesion appeared a few days later on r ankle, grew to a toney sized mark, roof of mouth and since (b)(6) it spread to other leg, thigh, hip, upper back, severe on arms and especially on r hand.And overnight in (b)(6) suddenly had 10 red dots on my lower leg, and they grew and then developed into the same lesions as the others and responded identical in appearance with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding clear diagnosis of autoimmune disorder, lab tests details patient¿s medical history, past medications, concomitant medications, allergic history, and other risk factors would aid in better case assessment.

Event Description

An autoimmune response [autoimmune disorder nos] unexplained body rash about 8 months ago after injection lesion appeared a few days later on r ankle, grew to a toney sized mark, roof of mouth and since july it spread to other leg, thigh, hip, upper back, severe on arms and especially on r hand.[rash] overnight in july suddenly had 10 red dots on my lower leg, and they grew and then developed into the same lesions as the others and responded identical in appearance [red rash] initial information received on 15-nov-2022 from canada regarding an unsolicited valid serious case received from the patient.This case involves a 78 years old female patient who reported an autoimmune response, unexplained body rash about 8 months ago after injection lesion appeared a few days later on r ankle, grew to a toney sized mark, roof of mouth and since (b)(6) it spread to other leg, thigh, hip, upper back, severe on arms and especially on r hand.And overnight in (b)(6) suddenly had 10 red dots on my lower leg, and they grew and then developed into the same lesions as the others and responded identical in appearance with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2022, the patient received synvisc injection in her right knee (lot, expiry date, strength, dose, route, frequency and indication - unknown).Information on batch number was requested.After an unknown latency patient had an unexplained body rash about 8 months ((b)(6) 2022) ago after getting the injection.Patient received in injection on (b)(6) 2022 in r(right) knee.First lesion appeared a few days later on my r ankle, then it grew to a toney sized mark.Went for cancer tests, and they were negative.Lesions then started on the roof of my mouth, and overnight in (b)(6) suddenly had 10 red dots on my lower leg (rash erythematous) (intervention required), and they grew and then developed into the same lesions as the others and responded identical in appearance.Then since (b)(6) it spread to my other leg, and thigh and hip and upper back.Then became severe on my arms and especially on my r hand (rash) (intervention required).Patient had 2 biopsies and 2 swabs and they indicated an autoimmune response (autoimmune disorder) (medically significant).She was taking steroid and cream presently.Action taken: unknown.Corrective treatment: steroids and cream.Outcome: unknown for all the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Event Description

An autoimmune response [autoimmune disorder nos] unexplained body rash about 8 months ago after injection lesion appeared a few days later on r ankle, grew to a toney sized mark, roof of mouth and since july it spread to other leg, thigh, hip, upper back, severe on arms and especially on r hand.[rash] overnight in july suddenly had 10 red dots on my lower leg, and they grew and then developed into the same lesions as the others and responded identical in appearance [red rash] case narrative: initial information received on 15-nov-2022 from canada regarding an unsolicited valid serious case received from the patient.This case involves a 78 years old female patient who reported an autoimmune response, unexplained body rash about 8 months ago after injection lesion appeared a few days later on r ankle, grew to a toney sized mark, roof of mouth and since july it spread to other leg, thigh, hip, upper back, severe on arms and especially on r hand.And overnight in july suddenly had 10 red dots on my lower leg, and they grew and then developed into the same lesions as the others and responded identical in appearance with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2022, the patient received synvisc one injection in her right knee (strength: 48mg/6ml, lot, expiry date, dose, route, frequency and indication - unknown).Information on batch number was requested.After a latency of few days approximately, patient had an unexplained body rash about 8 months ((b)(6) 2022) ago after getting the injection.Patient received in injection on (b)(6) 2022 in r(right) knee.First lesion appeared a few days later on my r ankle, then it grew to a toney sized mark.Went for cancer tests, and they were negative.Lesions then started on the roof of my mouth, and overnight in july suddenly had 10 red dots on my lower leg (rash erythematous) (intervention required), and they grew and then developed into the same lesions as the others and responded identical in appearance.Then since july it spread to my other leg, and thigh and hip and upper back.Then became severe on my arms and especially on my r hand (rash) (intervention required).Patient had 2 biopsies and 2 swabs and they indicated an autoimmune response (autoimmune disorder) (medically significant).She was taking steroid and cream presently.Action taken: not applicable.Corrective treatment: steroids and cream.Outcome: unknown for all the events.A product technical complaint (ptc) was initiated on 24-nov-2022 for synvisc one (batch number: unknown) with global ptc number (b)(4).The sample status was not available.The ptc was set in process.Additional information was received on 24-nov-2022 from healthcare professional (quality department).Product was updated.Ptc number along with strength was added.Text amended accordingly.

Event Description

An autoimmune response [autoimmune disorder nos] unexplained body rash about 8 months ago after injection lesion appeared a few days later on r ankle, grew to a toney sized mark, roof of mouth and since (b)(6) it spread to other leg, thigh, hip, upper back, severe on arms and especially on r hand.[rash] overnight in (b)(6) suddenly had 10 red dots on my lower leg, and they grew and then developed into the same lesions as the others and responded identical in appearance [red rash].Case narrative: initial information received on 15-nov-2022 from canada regarding an unsolicited valid serious case received from the patient.This case involves a 78 years old female patient who reported an autoimmune response, unexplained body rash about 8 months ago after injection lesion appeared a few days later on r ankle, grew to a toney sized mark, roof of mouth and since (b)(6) it spread to other leg, thigh, hip, upper back, severe on arms and especially on r hand.And overnight in (b)(6) suddenly had 10 red dots on my lower leg, and they grew and then developed into the same lesions as the others and responded identical in appearance with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2022, the patient received synvisc one injection in her right knee (strength: 48mg/6ml, lot, expiry date, dose, route, frequency and indication - unknown).Information on batch number was requested.After a latency of few days approximately, patient had an unexplained body rash about 8 months (b)(6) 2022 ago after getting the injection.Patient received in injection on (b)(6) 2022 in r(right) knee.First lesion appeared a few days later on my r ankle, then it grew to a toney sized mark.Went for cancer tests, and they were negative.Lesions then started on the roof of my mouth, and overnight in (b)(6) suddenly had 10 red dots on my lower leg (rash erythematous) (intervention required), and they grew and then developed into the same lesions as the others and responded identical in appearance.Then since (b)(6) it spread to my other leg, and thigh and hip and upper back.Then became severe on my arms and especially on my r hand (rash) (intervention required).Patient had 2 biopsies and 2 swabs and they indicated an autoimmune response (autoimmune disorder) (medically significant).She was taking steroid and cream presently.Action taken: not applicable.Corrective treatment: steroids and cream.Outcome: unknown for all the events.A product technical complaint (ptc) was initiated on 24-nov-2022 for synvisc one (batch number: unknown) with global ptc number (b)(4).The sample status was not available.The ptc was set in process.Additional information was received on 24-nov-2022 from healthcare professional (quality department).Product was updated.Ptc number along with strength was added.Text amended accordingly.Upon internal review on 24-nov-2022 case id (b)(4) (be deleted) was identified to be duplicate of (b)(4) (to be retained).Hence, all the information from the case (b)(4) (to be deleted) has been merged in case (b)(4).

• 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: 15851348
• MDR Text Key: 304177872
• Report Number: 2246315-2022-00141
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2022

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/28/2022; 11/30/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female