MAUDE Adverse Event Report: TEDEC-MEIJI FARMA SUPRAHYAL; SODIUM HYALURONATE

Lot Number M-6

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

Patient Problem Syncope (1610)

Event Date 05/09/2019

Event Type  Injury  

Event Description

Manufacturer reported that a female of (b)(6) years old with a medical history of arthrosis developed syncope after administration of suprahyal on(b)(6) 2019 with co-administration of platelet growth factors and lidocaine.No problem was evident during the first 30 minutes.After leaving the medical facility the patient developed weakness and syncope.A physician decided she should be observed in the emergency department.The patient was observed at the emergency department and "laboratory studies were normal.After 16 hours approximately the patient is discharged, patient does not refer new symptoms or new episodes.Date of recovery: (b)(6).Medicamenta ecuatoriana pharmacovigilance comment: in the patient it is difficult to determine the etiology of the syncope by the form of administration.The fact of using a combination of products in the same route can cause non-visible effects with each individual product.Relatedness of drug to reaction(s): medicinal product: suprahyal 25 mg x 1 iny x 1 jer solucion inyectable - drug reaction assess: syncope - source of assessment: tmf - method of assessment: karl-lasagna algorithm (amended) - causality assessment: possible.Manufacturer's comment: the causal role of sodium hyaluronate in the event developed cannot be ruled out as well as the other drugs administered in the same injection.".

• Brand Name: SUPRAHYAL
• Type of Device: SODIUM HYALURONATE
• Manufacturer (Section D): TEDEC-MEIJI FARMA; s.a. ctra. m-300,; km. 30,500-28802; alcalá de henares, madrid, ; SP
• Manufacturer Contact: dolores benedicto ; ctra. m-300,; km. 30,500-28802; alcala de henares madrid, ; SP
• MDR Report Key: 8755609
• MDR Text Key: 149925955
• Report Number: 3003184440-2019-00002
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 06/04/2019

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 Operator: No Information
• Device Expiration Date: 09/01/2021
• Device Lot Number: M-6
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 07/02/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR