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

Lot Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Anemia (1706); Diarrhea (1811); Fatigue (1849); Hair Loss (1877); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Rash (2033); Sepsis (2067); Hot Flashes/Flushes (2153); Malaise (2359); Swelling/ Edema (4577)

Event Date 11/18/2015

Event Type  Injury  

Event Description

Infected hickman line/catheter infection.Catheter infection.Infected hickman line/infected hickman line [device related infection].Central (hickman) line infection [central line infection].Infected hickman line [vascular access related infection].Infected hickman line/vascular access related infection.Sepsis.Osteonecrosis of jaw/osteonecrosis of jaw.Ejection fraction decreased.Left ventricular ejection fraction decreased/ejection fraction decreased/reduced ejection/ejection fraction decreased.Reduced ejection fraction/reduced left/ejection fraction decreased (2nd occurrence).Left ventricular ejection fraction decreased (1st occurrence).Reduced ejection fraction/ left ventricular ejection fraction decreased(2nd occurrence).Left ventricular ejection fraction decreased.Reduced lvef - 2nd episode/reduced lvef.Mucositis/mucositis.Gastroesophageal reflux disease.Gastrooesophageal reflux disease/gastrooesophageal reflux disease.Swelling of gums/gum swelling.Diarrhoea.Lymphoedema.Anaemia.Alopecia.Nose bleed.Fatigue.Hot flush on face.Rash.Flu like symptoms.Trastuzumab used via subcutaneous route [off label use in unapproved route of administration].Trastuzumab used along with pertuzumab/trastuzumab used along with pertuzumab (off label use).Case narrative: initial information received on (b)(6) 2022 regarding an unsolicited valid serious case received from health authorities of united kingdom under reference (b)(4).This case involves a 45 yrs old female patient who had infected hickman line/ catheter infection, catheter infection, vascular access related infection/ infected hickman line, sepsis, osteonecrosis of jaw/osteonecrosis of jaw, ejection fraction decreased, left ventricular ejection fraction decreased /ejection fraction decreased (2nd occurrence)/reduced ejection fraction/ ejection fraction decreased, left ventricular ejection fraction decreased/ejection fraction decreased/reduced ejection fraction/ejection fraction decreased (1st occurrence), reduced ejection fraction/ left ventricular ejection fraction decreased/reduced left/ ejection fraction decreased (2nd occurrence), left ventricular ejection fraction decreased, reduced left - second episode/reduced left, diarrhoea, mucositis/mucositis, mucositis, gastroesophageal reflux disease, , lymphoedema, anaemia, anaemia, alopecia nose bleed, fatigue, hot flush on face, rash/ rash, flu like symptoms, swelling of gums, trastuzumab used via subcutaneous route & trastuzumab used along with pertuzumab/trastuzumab used along with pertuzumab (off label use)/off label use while being treated with docetaxel, docetaxel, exemestane, hyaluronidase, hyaluronidase, ib&ronate sodium, ib&ronic acid, trastuzumab, trastuzumab, trastuzumab, docetaxel [taxotere], hyaluronate sodium [sodium hyaluronate], ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate [bonviva], exemestane [aromasin], trastuzumab [herceptin], pertuzumab [perjeta], pertuzumab, vorhyaluronidase alfa [rhuph20], vorhyaluronidase alfa & vorhyaluronidase alfa & with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history included malaise with for 48 hours, mucosal inflammation on (b)(6) 2015, gingival swelling in (b)(6) 2015, vascular device infection, diarrhoea on (b)(6) 2015, rash on (b)(6) 2015, ejection fraction decreased from (b)(6) 2016, vascular device infection from (b)(6) 2015 to (b)(6) 2015 with central line infection, alopecia on (b)(6) 2016, anaemia from (b)(6) 2015 to (b)(6) 2016, epistaxis in (b)(6) 2015, influenza like illness in (b)(6) 2015, fatigue from (b)(6) 2015 to (b)(6) 2016, device related infection from (b)(6) 2015 to (b)(6) 2015, lymphoedema from (b)(6) 2015 to (b)(6) 2016, hot flush in (b)(6) 2015, fatigue on (b)(6) 2015 & alopecia from (b)(6) 2015 to (b)(6) 2016.The patient's past medical treatment included tazocin & gentamicin.The patient's past & family history were not provided.At the time of the event, the patient had ongoing osteonecrosis of jaw in (b)(6) 2018, sepsis on (b)(6) 2015, metastases to bone, gastrooesophageal reflux disease on (b)(6) 2015 & breast cancer metastatic.Concomitant medications included benzydamine hydrochloride for gingival swelling, metastases to bone & mucosal inflammation; bisoprolol; calcium; ciprofloxacin for vascular device infection; amoxycillin, potassium clavulanate (co-amoxiclav) for vascular device infection; denosumab; dexamethasone; gentamicin for device related infection; ib&ronic acid for metastases to bone; iron for serum ferritin decreased; meropenem for device related infection; paracetamol for device related infection; ramipril for ejection fraction decreased; piperacillin sodium, tazobactam sodium (tazocin) for device related infection; & denosumab (xgeva).On (b)(6) 2015, the patient started taking herceptin 483 mg, qd (every day) via intravenous route (dose form: 230; cumulative dose: 2898.0 mg) (with an unknown formulation, strength, batch number & expiry date) & then since on (b)(6) 2015 to (b)(6) 2016, the patient started dose at 600 mg every day via intravenous route (with an unknown formulation, strength, batch number & expiry date) for breast cancer metastatic.On (b)(6) 2015, the patient started taking docetaxel at a dose of 120 mg, every 3 weeks via intravenous route (with an unknown formulation, strength, batch number & expiry date) & then since on (b)(6) 2015 to (b)(6) 2016, the patient started dose at 600 mg every 3 weeks (600 mg, q3w) via intravenous route (with an unknown formulation, strength, batch number & expiry date) for breast cancer metastatic.On 18 may 2015, the patient started taking exemestane at a dose of 25mg every day (cumulative dose:28900mg) via oral route (with an unknown formulation, strength, batch number & expiry date) for breast cancer metastatic & metastases to bone.On (b)(6) 2015, the patient started taking bonviva at a dose of 50 mg, qd (every day) (dose form: 245) via oral route (with an unknown formulation, strength, batch number & expiry date) for bone metastases.On (b)(6) 2015, the patient started taking ib&ronic at a dose of 50 mg daily via oral route (with an unknown formulation, strength, batch number & expiry date) for bone metastases.On (b)(6) 2015, the patient started taking two doses of ib&ronate sodium were both given at 50 mg once a day (50 mg, qd) via oral use (with an unknown formulation, strength, batch number & expiry date) for bone metastases.On (b)(6) 2015, the patient started taking trastuzumab at a dose of at 483 mg at 1 day (230 mg, qd loading dose) (cumulative dose: 2400mg) via intravenous route on (with an unknown formulation, strength, batch number & expiry date) & then since on (b)(6) 2015, the patient started dose at 600 mg every 3 weeks (600 mg, q3w) via subcutaneous route (with an unknown formulation, strength, batch number & expiry date) & then since (b)(6) 2016, the patient started dose at 600 mg every 3 weeks (600 mg, q3w loading dose) via subcutaneous route (with an unknown formulation, strength, batch number & expiry date) & then since (b)(6) 2015, the patient started dose at 600 mg every 3 weeks (600 mg, q3w) via subcutaneous route on (b)(6) 2015 (duration: 85 dys); 600 mg every 3 weeks (600 mg, q3w) via intravenous route (with an unknown formulation, strength, batch number & expiry date) & then since on (b)(6) 2015 to (b)(6) 2016, the patient started dose at 483 mg at 1 day (230 mg, qd loading dose) (cumulative dose: 2400mg) via intravenous route (with an unknown formulation, strength, batch number & expiry date) & then since on (b)(6) 2016, the patient started dose at 1800 mg every 1 week (600 mg, tiw) via intravenous route (with an unknown formulation, strength, batch number & expiry date) for breast cancer metastatic.On (b)(6) 2015, the patient started taking pertuzumab solution for infusion at a dose of 840 mg total via intravenous route (with an unknown strength, batch number & expiry date) & then since on (b)(6) 2015, the patient started dose at 420 mg every 3 weeks (420 mg, q3w)(cumulative dose: 21140mg) via intravenous route (with an unknown strength, batch number & expiry date) & then since on (b)(6) 2015 to (b)(6) 2016, the patient started dose at 420 mg every 3 weeks (420 mg, q3w maintenance dose) via intravenous use (with an unknown strength, batch number & expiry date) & then since on (b)(6) 2016, the patient started dose at 840 mg total (840 mg, 1x (loading dose); in total via intravenous use (with an unknown strength, batch number & expiry date) & then since on (b)(6) 2016, the patient started dose 420 mg every 3 weeks (420 mg, q3w maintenance dose)(cumulative dose: 14639.9999mg) via intravenous use (with an unknown strength, batch number & expiry date) for breast cancer metastatic.On (b)(6) 2015, the patient started taking taxotere at a dose of at 120 mg every 3 weeks (120 mg, q3w) via intravenous route (with an unknown formulation, strength, batch number & expiry date) for breast cancer metastatic.On (b)(6) 2015, the patient started taking vorhyaluronidase alfa at a dose of at 600 mg every 3 weeks (600 mg, q3w maintenance dose)(cumulative dose: 30200mg) via subcutaneous (with an unknown formulation, strength, batch number & expiry date) & then since on (b)(6) 2016, the patient started dose at 600 mg every 3 week (600 milligram, q3w) via subcutaneous (with an unknown formulation, strength, batch number & expiry date) & then since on (b)(6) 2016, was given at unspecified dose & frequency (stopped; ;) via subcutaneous route on unspecified date, 600 mg every 3 weeks (600 mg, q3w) via subcutaneous (with an unknown formulation, strength, batch number & expiry date) for breast cancer metastatic.On (b)(6) 2015, the patient started taking hyaluronidase at a dose of 600 mg (600 mg, qw) via subcutaneous route (with an unknown formulation, strength, batch number & expiry date & indication ) & then since on(b)(6) 2015, the patient started dose at 600 mg every 3 weeks (600 mg, q3w) at unspecified route (with an unknown formulation, strength, batch number & expiry date & indication) & then since on (b)(6) 2016, the patient given at unspecified dose & frequency (unk) via oral route (with an unknown formulation, strength, batch number & expiry date) & then since on (b)(6) 2016, the patient started dose at unspecified dose, frequency & route (unk) (with an unknown formulation, strength, batch number & expiry date & indication) & then since on (b)(6) 2016, the patient started dose at 600 mg every 3 weeks (600 mg, q3w) via subcutaneous route on (with an unknown formulation, strength, batch number & expiry date & indication) & then since on (b)(6) 2016, the patient started dose at 600 milligram q3w via subcutaneous route (with an unknown formulation, strength, batch number & expiry date & indication).On (b)(6) 2015 to (b)(6) 2016, the patient started taking perjeta dose at 420 mg, (qd (every day) (dose form: 230; cumulative dose: 2600.8333 mg) via intravenous route (with an unknown formulation, strength, batch number & expiry date) & then since on (b)(6) 2016, the patient started dose at 840 mg (loading dose; dose form: 230) via intravenous route (with an unknown formulation, strength, batch number & expiry date) & then since on (b)(6) 2016, the patient started taking every 1 day (one cycle (loading dose); dose form: 230 via intravenous route, 420 mg, qd (every day) (maintenance dose)(dose form: 230; cumulative dose: 143220.0 mg) via intravenous route (with an unknown formulation, strength, batch number & expiry date) & then since on (b)(6) 2015, the patient started dose at 420 mg every 3 week (maintenance dose)(dose form: 230; cumulative dose: 320.0 mg) via intravenous route (with an unknown formulation, strength, batch number & expiry date)for breast cancer metastatic.It was reported fatigue (fatigue; onset date: (b)(6) 2015; latency 5 dys for docetaxel, 2 mos 22 dys, exemestane, 2 mos 22 dys hyaluronidase, 2 mos 22 dys for ib&ronate sodium, 2 mos 22 dys for ib&ronic acid 6 dys for trastuzumab 2 mos 22 dys for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 5 dys for trastuzumab, 5 dys for pertuzumab, 5 dys for vorhyaluronidase alfa).Fatigue (fatigue; onset date: (b)(6) 2015; latency 5 dys for docetaxel, 2 mos 22 dys, exemestane, 2 mos 22 dys hyaluronidase, 2 mos 22 dys for ib&ronate sodium, 2 mos 22 dys for ib&ronic acid, 6 dys for trastuzumab 2 mos 22 dys for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 5 dys for trastuzumab, 5 dys for pertuzumab, 5 dys for vorhyaluronidase alfa).Nosebleed/ nose bleed (epistaxis; onset date: (b)(6) 2015; latency: 5 dys for docetaxel, 2 mos 22 dys exemestane, 2 mos 22 dys hyaluronidase, 2 mos 22 dys for ib&ronate sodium, 2 mos 22 dys for ib &ronic acid, 6 dys for trastuzumab, 2 mos 22 dys for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 5 dys for trastuzumab, 5 dys for pertuzumab, 5 dys for vorhyaluronidase alfa.Diarrhoea (diarrhoea; onset date: in (b)(6) 2015; latency: unknown).Mucositis/mucositis (mucosal inflammation; onset date: (b)(6) 2015; latency: 5 dys of docetaxel, 2 mos 22 dys exemestane, 2 mos 22 dys hyaluronidase, 2 mos 22 dys ib&ronate sodium, 2 mos 22 dys ib&ronic acid, 6 dys trastuzumab, unknown latency docetaxel, 2 mos 22 dys ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 5 dys trastuzumab, 5 dys pertuzumab, 5 dys vorhyaluronidase alfa.Gastroesophageal reflux disease (gastrooesophageal reflux disease; onset date: (b)(6) 2015; latency: 5 dys docetaxel, 2 mos 22 dys exemestane, 2 mos 22 dys hyaluronidase, 2 mos 22 dys ib&ronate sodium, 2 mos 22 dys ib&ronic acid, 6 dys trastuzumab, 2 mos 22 dys ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 5 dys trastuzumab, 5 dys pertuzumab, 5 dys of vorhyaluronidase alfa).Lymphoedema (lymphoedema; onset date: (b)(6) 2015; latency: 5 dys docetaxel, 2 mos 22 dys of exemestane, 2 mos 22 dys ib&ronate sodium, 2 mos 22 dys ib&ronic acid, 6 dys trastuzumab, 2 mos 22 dys ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 5 dys trastuzumab, 5 dys pertuzumab, 5 dys vorhyaluronidase alf).Anaemia (anaemia; onset date: (b)(6) 2015; latency: 5 dys for docetaxel, 2 mos 22 dys for exemestane, 2 mos 22 dys for hyaluronidase, 2 mos 22 dys for ib&ronate sodium, 2 mos 22 dys for ib&ronic acid, 6 dys for trastuzumab, 2 mos 22 dys ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 5 dys for trastuzumab , 5 dys for pertuzumab, 5 dys for vorhyaluronidase alfa.Hot flush on face/hot flush on face/hot flushes facial/hot flush on face (hot flush; onset date: (b)(6) 2015; latency: unknown).On (b)(6) 2015 the patient developed a non-serious rash/ rash (rash; onset date: (b)(6) 2015; latency: 6 dys following the first dose intake for docetaxel, 2 mos 23 dys for exemestane, 2 mos 23 dys hyaluronidase, 2 mos 23 dys for ib&ronate sodium, 2 mos 23 dys of ib&ronic acid, 7 dys for trastuzumab, 2 mos 23 dys ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 6 dys for pertuzumab, 6 dys for vorhyaluronidase alfa.Flue like symptoms (influenza like illness; onset date: (b)(6) 2015; latency: unknown).Swelling of gums/gum swelling (gingival swelling; onset date: (b)(6) 2015; latency: unknown).Swelling of gums/gum swelling (gingival swelling onset date: (b)(6) 2015; latency: 5 dys docetaxel, 2 mos 22 dys exemestane, 2 mos 22 dys hyaluronidase, 2 mos 22 dys ib&ronate sodium, 2 mos 22 dys ib&ronic acid, 6 dys for trastuzumab, 2 mos 22 dys ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 5 dys trastuzumab, 5 dys pertuzumab, 5 dys vorhyaluronidase alfa).Mucositis (mucosal inflammation; onset date: (b)(6) 2015; latency: 21 dys docetaxel, 3 mos 7 dys exemestane, 3 mos 7 dys hyaluronidase, 3 mos 7 dys of ib&ronate sodium, 3 mos 7 dys ib&ronic acid, 22 dys following the first dose intake of trastuzumab, 11 dys docetaxel, 3 mos 7 dys of ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 21 dys following the last dose intake of trastuzumab, 21 dys following the first dose pertuzumab, 21 dys vorhyaluronidase alfa).Gastrooesophageal reflux disease / gastrooesophageal reflux disease (gastrooesophageal reflux disease onset date: (b)(6) 2015; latency: 21 dys docetaxel, 3 mos 7 dys exemestane, 3 mos 7 dys hyaluronidase, 3 mos 7 dys ib&ronate sodium, 3 mos 7 dys of ib&ronic acid, 22 dys trastuzumab, 11 dys docetaxel, 3 mos 7 dys ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 21 dys trastuzumab, 21 dys pertuzumab, 21 dys vorhyaluronidase alfa).Alopecia/alopecia (alopecia; onset date: (b)(6) 2015; latency:) 1 mos 4 dys for docetaxel, 3 mos 21 dys exemestane, 3 mos 21 dys hyaluronidase, 3 mos 21 dys for ib&ronate sodium, 3 mos 21 dys for ib&ronic acid, 1 mos 5 dys for trastuzumab, 25 dys for docetaxel, 14 dys hyaluronate sodium, 3 mos 21 dys ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 14 dys for trastuzumab, 1 mos 4 dys for pertuzumab, 1 mos 4 dys for vorhyaluronidase alfa).Anaemia (anaemia; onset date: (b)(6) 2015; latency 2 mos 1 day for docetaxel, 4 mos 18 dys for exemestane, 4 mos 18 dys for hyaluronidase, 4 mos 18 dys for ib&ronate sodium, 4 mos 18 dys for ib&ronic acid, 2 mos 2 dys for trastuzumab, 1 mos 22 dys for docetaxel, 1 mos 11 dys for hyaluronate sodium, 4 mos 18 dys for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 1 mos 11 dys for trastuzumab, 2 mos 1 day for pertuzumab, 2 mos 1 day for vorhyaluronidase alfa).Nosebleed (epistaxis; onset date: (b)(6) 2015; latency: unknown).Lymphodoema/ lymphoedema (lymphoedema ; onset date: (b)(6) 2015; latency: 2 mos 22 dys docetaxel, 5 mos 8 dys exemestane, 5 mos 8 dys hyaluronidase, 5 mos 8 dys ib&ronate sodium, 5 mos 8 dys ib&ronic acid, 2 mos 23 dys trastuzumab, 2 mos 12 dys docetaxel, 2 mos 1 day of hyaluronate sodium, 5 mos 8 dys following the first dose intake & (unknown latency) following the last dose intake of ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 2 mos 1 day trastuzumab, 2 mos 22 dys pertuzumab, 2 mos 22 dys vorhyaluronidase alfa).Infected hickman line/catheter infection (device related infection); onset date: (b)(6) 2015; latency: 3 mos 14 dys for docetaxel, 6 mos for exemestane, 6 mos for hyaluronidase, 6 mos for ib&ronate sodium, 6 mos for ib&ronic acid, 3 mos 15 dys for trastuzumab, 3 mos 4 dys for docetaxel, 2 mos 24 dys for hyaluronate sodium, 6 mos for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 2 mos 24 dys for trastuzumab, 3 mos 14 dys for pertuzumab, 3 mos 14 dys for vorhyaluronidase alfa).Infected hickman line/ catheter infection (device related infection; onset date: (b)(6) 2015; latency: 2 mos 24 dys after starting use of hylan g-f 20 & sodium hyaluronate.Catheter infection (device related infection); onset date: (b)(6) 2015; latency: 3 mos 3 dys after starting use of hylan g-f 20 & sodium hyaluronate.Infected hickman line/infected hickman line (device related infection; onset date: (b)(6) 2015; latency: 3 mos 3 dys after starting use of hylan g-f 20 & sodium hyaluronate.Central (hickman) line infection; onset date: (b)(6) 2015; latency: 1 yr 13 dys after starting use of hylan g-f 20 & sodium hyaluronate.Infected hickman line (vascular device infection; onset date: (b)(6) 2015; latency) 3 mos 3 dys after starting use of hylan g-f 20 & sodium hyaluronate.Catheter infection (device related infection; onset date: (b)(6) 2015; latency: 3 mos 24 dys for docetaxel, 6 mos 10 dys for exemestane, 6 mos for hyaluronidase, 6 mos 10 dys for ib&ronate sodium, 6 mos 10 for ib&ronic acid, 3 mos 25 dys for trastuzumab, 3 mos 14 dys for docetaxel, 3 mos 3 dys for hyaluronate sodium, 6 mos 10 dys for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 3 mos 3 dys for trastuzumab, 3 mos 24 dys for pertuzumab, 3 mos 24 for vorhyaluronidase alfa.Infected hickman line/infected hickman line; onset date: (b)(6) 2015; latency: 3 mos 24 dys for docetaxel, 6 mos 10 dys for exemestane, 6 mos 10 dys for hyaluronidase, 6 mos 10 dys for ib&ronate sodium, 6 mos 10 dys for ib&ronic acid, 3 mos 25 dys for trastuzumab, 3 mos 14 dys for docetaxel, 3 mos 3 dys for hyaluronate sodium, 6 mos 10 dys for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 3 mos 3 dys for trastuzumab, 3 mos 24 dys for pertuzumab, 3 mos 24 dys for vorhyaluronidase alfa.Infected hickman line (vascular device infection; onset date: (b)(6) 2015; latency: 3 mos 24 dys for docetaxel, 6 mos for exemestane, 6 mos 10 dys for hyaluronidase, 6 mos 10 dys for ib&ronate sodium, 6 mos 10 dys for ib&ronic acid, 3 mos 25 dys for trastuzumab, 3 mos 4 dys for docetaxel, 2 mos 24 dys for hyaluronate sodium, 6 mos for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, , 2 mos 24 dys for trastuzumab, 3 mos 14 dys for pertuzumab, 3 mos 14 dys for vorhyaluronidase alfa).Catheter infection (device related infection; onset date: (b)(6) 2015; latency: 3 mos 24 dys for docetaxel, 6 mos 10 dys for exemestane, 6 mos for hyaluronidase, 6 mos 10 dys for ib&ronate sodium, 6 mos 10 for ib&ronic acid, 3 mos 25 dys for trastuzumab, 3 mos 14 dys for trastuzumab, 3 mos 14 dys for docetaxel, 3 mos 3 dys for hyaluronate sodium, 6 mos 10 dys for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 3 mos 3 dys for trastuzumab, 3 mos 24 dys for pertuzumab, 3 mos 24 for vorhyaluronidase alfa.Infected hickman line/vascular access related infection; onset date: (b)(6) 2015; latency: 3 mos 24 dys for docetaxel, 6 mos 10 dys for exemestane, 6 mos 10 dys for hyaluronidase, 6 mos 10 dys for ib&ronate sodium, 6 mos 10 dys for ib&ronic acid, 3 mos 25 dys for trastuzumab, 3 mos 14 dys for docetaxel, 3 mos 3 dys for hyaluronate sodium, 6 mos 10 dys for ib&ronate sodium, 6 mos 10 dys for ib&ronic acid, 6 mos 10 dys for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 3 mos 3 dys for trastuzumab, 3 mos 23 dys for pertuzumab, 3 mos 24 dys for vorhyaluronidase alfa).Sepsis; onset date: (b)(6) 2015; latency: 3 mos 14 dys for docetaxel, 6 mos 10 dys exemestane, 6 mos 10 dys for hyaluronidase, 6 mos 10 dys for ib&ronate sodium, 6 mos 10 dys for ib&ronic acid, 3 mos 25 dys for trastuzumab3 mos 14 dys for docetaxel, 3 mos 3 dys for hyaluronate sodium, 6 mos 10 dys for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 3 mos 24 dys for trastuzumab, 3 mos 24 dys for pertuzumab, 3 mos 24 for vorhyaluronidase alfa).Left ventricular ejection fraction decreased.Onset date: (b)(6) 2016; latency: 7 mos 18 dys for docetaxel, 10 mos 4 dys for exemestane, 14 dys for hyaluronidase, 10 mos 4 dys for ib&ronate sodium, 10 mos 4 dys for ib&ronic acid, 7 mos 19 dys for trastuzumab, 3 mos 5 dys for trastuzumab,, 7 mos 8 dys for docetaxel, 6 mos 28 dys for hyaluronate sodium, 10 mos 4 dys for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 6 mos 28 dys for trastuzumab, 7 mos 18 for pertuzumab, 7 mos 18 dys for vorhyaluronidase alfa).Left ventricular ejection fraction decreased/ejection fraction decreased/reduced ejection fraction/ejection fraction decreased (1st occurrence); onset date: on (b)(6) 2016; latency: 7 mos 18 dys for docetaxel, 10 mos 4 dys exemestane, 14 dys hyaluronidase, 10 mos 4 dys for ib&ronate sodium, 10 mos 4 dys, for ib&ronic acid, 7 mos 19 dys for trastuzumab, 3 mos 5 for trastuzumab, 7 mos 8 dys for docetaxel, , 6 mos 28 dys for hyaluronate sodium, 10 mos 4 dys for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate , 6 mos 28 dys for trastuzumab, 7 mos 18 dys for pertuzumab, 7 mos 18 dys for vorhyaluronidase alfa).Left ventricular ejection fraction decreased (ejection fraction decreased; onset date: (b)(6) 2016; latency: 7 mos 18 dys for docetaxel, 10 mos 4 dys exemestane, 14 dys for hyaluronidase,10 mos 4 dys for ib&ronate sodium, , 10 mos 4 dys for ib&ronic acid, 7 mos 19 dys for trastuzumab, 3 mos 5 dys for trastuzumab, 7 mos 8 dys for docetaxel, 6 mos 28 dys for hyaluronate sodium, 10 mos 4 dys ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 6 mos 28 dys for trastuzumab, 7 mos 18 dys pertuzumab, 7 mos 18 dys vorhyaluronidase alfa).Educed left-2nd episode/reduced left (ejection fraction decreased); onset date: (b)(6) 2016; latency: 3 yrs 9 mos 6 dys for docetaxel, 3 r yrs 11 mos 23 dys exemestane, 3 yrs 2 mos 2 dys for hyaluronidase, 3 yrs 11 mos 23 dys for ib&ronate sodium, 3 yrs 11 mos 23 dys for ib&ronic acid, 2 yrs 10 mos 18 dys for trastuzumab, 3 yrs 9 mos 7 dys following the first dose intake & 3 yrs 5 mos 23 dys following the last dose intake of for trastuzumab, 3 yrs 4 mos 24 dys following the first dose intake & 3 yrs 2 mos 1 day of for trastuzumab, 3 yrs 8 mos 27 dys for docetaxel, 3 yrs 8 mos 16 dys for hyaluronate sodium, 3 yrs 11 mos 23 dys ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 3 yrs 8 mos 16 dys for trastuzumab, 3 yrs 9 mos 6 dys pertuzumab, 3 yrs 9 mos 6 dys vorhyaluronidase alfa).Central (hickman) line infection (vascular device infection; onset date: (b)(6) 2016; latency: 1 yr 1 mos 3 dys for docetaxel, 1 yr 3 mos 20 dys for exemestane, 6 mos for hyaluronidase, 1 yr 3 mos 20 dys for ib&ronate sodium, 1 yr 3 mos 20 dys for ib&ronic acid, 2 mos 15 dys for trastuzumab, 1 yr 1 mos 4 dys for trastuzumab, 8 mos 21 dys for trastuzumab, 1 yr 24 dys for docetaxel , 1 yr 13 dys for hyaluronate sodium, 1 yr 3 mos 20 dys for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 1 yr 13 dys for trastuzumab, 1 yr 1 mos 3 dys for pertuzumab, 1 yr 1 mos 3 dys for vorhyaluronidase alfa.Trastuzumab used along with pertuzumab/trastuzumab used along with pertuzumab (off label use)/off label use (off label use; onset date: (b)(6) 2016; latency: 1 yr 1 mos 4 dys docetaxel, 1 yr 3 mos 21 dys exemestane, 6 mos hyaluronidase, 1 yr 3 mos 21 dys ib&ronate sodium, 1 yr 3 mos 21 dys ib&ronic acid, 2 mos 16 dys trastuzumab, 1 yr 1 mos 5 dys trastuzumab, 8 mos 22 dys trastuzumab, 1 yr 25 dys docetaxel, 1 yr 14 dys hyaluronate sodium, 1 yr 3 mos 21 dys ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 1 yr 14 dys trastuzumab, 1 yr 1 mos 4 dys pertuzumab, 1 yr 1 mos 4 dys vorhyaluronidase alfa).Osteonecrosis of jaw; onset date: (b)(6) 2018; latency: unknown.Ejection fraction decreased; onset date: (b)(6) 2016; latency: 7 mos 18 dys for docetaxel, 10 mos 4 dys for exemestane, 14 dys for hyaluronidase, 10 mos 4 dys for ib&ronate sodium, 10 mos 4 for ib&ronic acid, 7 mos 19 dys for trastuzumab, 3 mos 5 dys for trastuzumab, 7 mos 8 dys for docetaxel, 6 mos 28 dys for hyaluronate sodium, 10 mos 4 dys for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 6 mos 28 dys for trastuzumab, 7 mos 18 dys for pertuzumab, 7 mos 18 dys for vorhyaluronidase alfa).Ejection fraction/reduced left/ejection fraction decreased (2nd occurrence); onset date: on (b)(6) 2018; latency: 2 yrs 11 mos 13 dys for docetaxel, 3 yrs 2 mos for exemestane, 2 yrs 4 mos 9 dys for hyaluronidase 3 yrs 2 mos for ib&ronate sodium, 3 yrs 2 mos ib&ronic acid, 2 yrs 25 dys for trastuzumab, 2 yrs 7 mos for trastuzumab, 2 yrs 11 mos 3 dys for docetaxel, 2 yrs 10 mos 23 dys for hyaluronate sodium, 3 yrs 2 mos for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 2 yrs 10 mos 23 dys for trastuzumab, 2 yrs 11 mos 13 dys for pertuzumab, 2 yrs 11 mos 13 dys for vorhyaluronidase alfa).Reduced ejection fraction/left ventricular ejection fraction decreased (2nd occurrence); onset date: (b)(6) 2018; latency: 2 yrs 11 mos 13 dys for docetaxel, 3 yrs 2 mos for exemestane, 2 yrs 4 mos 9 dys for hyaluronidase, 3 yrs 2 mos 3 yrs 2 mos for ib&ronate sodium, 3 yrs 2 mos for ib&ronic acid, 2 yrs 25 dys for trastuzumab, 2 yrs 7 mos for trastuzumab, 2 yrs 11 mos 3 dys for docetaxel, 2 yrs 10 mos 23 dys hyaluronate sodium, 3 yrs 2 mos for ib&ronate sodium monohydrate, ib&ronic acid, ib&ronic acid monosodium salt monohydrate, 2 yrs 10 mos 23 dys for trastuzumab, 2 yrs 11 mos 13 dys for pertuzumab, 2 yrs 11 mos 13 dys for vorhyaluronidase alfa).Trastuzumab used via subcutaneous route (off label use: onset date: unknown; latency: same day).Laboratory data included biopsy: rule out inflammatory bowel disease.Blood albumin: unknown, 24.Culture blood: unknown, abnormal.Blood culture: abnormal, abnormal, hickman line p.

• Brand Name: SYNVISC
• 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: 16262666
• MDR Text Key: 308590673
• Report Number: 2246315-2022-00137
• 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: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: BENZYDAMINE HYDROCHLORIDE,UNKNOWN.; BISOPROLOL (BISOPROLOL),UNKNOWN.; CALCIUM (CALCIUM),UNKNOWN.; CIPROFLOXACIN (CIPROFLOXACIN),UNKNOWN.; CO-AMOXICLAV [AMOXICILLIN,CLAVULANATE POTASSIUM],U.; DENOSUMAB (DENOSUMAB),UNKNOWN.; DEXAMETHASONE (DEXAMETHASONE),UNKNOWN.; GENTAMICIN (GENTAMICIN),UNKNOWN.; IBANDRONIC ACID (IBANDRONIC ACID),UNKNOWN.; IRON (IRON),UNKNOWN.; MEROPENEM (MEROPENEM),UNKNOWN.; PARACETAMOL (PARACETAMOL),TABLET.; RAMIPRIL (RAMIPRIL),TABLET.; TAZOCIN,UNKNOWN.; XGEVA (DENOSUMAB),UNKNOWN.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 83 KG