MAUDE Adverse Event Report: SEIKAGAKU CORPORATION ARTZ DISPO; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Insufficient Information (3190)

Patient Problem Anaphylactic Shock (1703)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

We are investigating the case in detail.This case was reported from a physician.The physician considered that the event was not serious but we considered that the event was serious because the event was reported as anaphylactic shock like symptoms.The physician considered that the event was probably related to artz dispo.We considered that the event was probably related because the event developed soon after the injection.

Event Description

On (b)(6) 2020 - a (b)(6) year-old male patient received an injection of artz dispo to shoulder periarthritis.Ten minutes later he had flush on face, hand and eyelid.He had difficulty breathing and anaphylactic shock like symptoms.He stayed in treatment room for one hour.He recovered and went home.

Manufacturer Narrative

This is a definitive report.This additional information was reported from the physician.This case is no longer subject to mdr.The physician changed the event term from anaphylactic shock to hypersensitivity, and evaluated its seriousness as not serious.We agreed with the physician's assessment.The physician considered that the relationship between the event and artz dispo was highly probable.Our company considered that the event was related to artz dispo because hypersensitivity was listed in the package insert.

Event Description

(b)(6) 2020: a 69 year-old male patient received injections of carbocain (mepivacaine), depo-medrol(methylprednisolone) and artz dispo to right shoulder for periarthritis scapulohumeralis at 3:45 pm.At 4:05 pm, he had binocular hyperemia and eyelid swelling, facial flush, redness and itching in the palms of both hands, itching on the abdomen.At 4:10 pm, his blood pressure was 137/94 and pulse was 107.He stated flushing and fast heartbeat.His intravenous route was secured with 250 ml physio140 (glucose-added ringer's solution) and 20 ml lemigen (glycyrrhizinate).His face was iced with a wet towel.At 4:20 pm, his blood pressure was 132/94 and pulse was 62.He had uncomfortable in the throat and mild suffocation.At 4:30 pm, he took one tablet of 30 mg oxatowa (oxatomide) and 10mg takecab (vonoprazan).At 4:50 pm, his blood pressure was 140/104 and pulse was 69.He developed complicated premature constractions.He felt chill slightly and shivered with cold.His body temperature was 36.2 degrees.At 5:23 pm, his binocular hyperemia, facial flush were improving.His itching in the palms of both hands and on the abdomen were improved.He was prescribed 5mg allelock(olopatadine).He went to home by walk.His symptoms were improved mostly before sleeping.(b)(6) 2020: he recovered when he got up.

• Brand Name: ARTZ DISPO
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0 005; JA 100-0005
• MDR Report Key: 10935558
• MDR Text Key: 219198684
• Report Number: 9612392-2020-00014
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P980044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AZOSEMIDE; CANDESARTAN (CANDESARTAN CILEXETIL); CARBOCAIN (MEPIVACAINE HYDROCHLORIDE); CARVEDILOL; CARVEDILOL; DEPO_MEDROL (METHYLPREDNISOLONE ACETATE); FEBURIC (FEBUXOSTAT); FUROSEMIDE; GENTACIN (GENTAMICIN SULFATE); LIXIANA (EDOXABAN TOSILATE HYDRATE); LIXIANA (EDOXABAN TOSILATE HYDRATE); LOSARTAN POTASSIUM; SPIRONOLACTONE; TAKECAB (VONOPRAZAN FUMARATE); CANDESARTAN (CANDESARTAN CILEXETIL); CARVEDILOL; FUROSEMIDE; LIXIANA (EDOXABAN TOSILATE HYDRATE)
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 89