MAUDE Adverse Event Report: FIDIA FARMACEUTICI S.P.A. HYMOVIS

Lot Number F05380

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/14/2023

Event Type  Injury  

• Brand Name: HYMOVIS
• Type of Device: HYMOVIS
• Manufacturer (Section D): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica 3/a; abano terme, padua 35031 ; IT 35031
• Manufacturer (Section G): FIDIA FARMACERUTICI S.P.A.; via ponte della fabbrica 3/a; abano terme, padua 35031 ; IT 35031
• Manufacturer Contact: giuseppina lo castro ; via ponte della fabbrica 3/a; abano terme, padua 35031 ; IT 35031
• MDR Report Key: 16902610
• Report Number: 9610200-2023-00002
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2023

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: Health Professional
• Device Lot Number: F05380
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female