MAUDE Adverse Event Report: FERRING / BIO - TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA 10MG/ML SYRINGE; ACID, HYALURONIC, INTRAARTICULAR

Lot Number P14216A

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

Patient Problem Bacterial Infection (1735)

Event Date 09/23/2019

Event Type  Injury  

Event Description

The pt was hospitalized, dates unk.Reason: combat infection (knee replacement occurred (b)(6) 2019).The pt reported was hospitalized for bacterial infection from old bladder surgery, has been experiencing reactions (possibly allergic) to many antibiotics, unable to subdue this bacteria, is consulted an infectious disease specialist then an allergist to determine if reactions are truly allergic reactions.Mdo-info: (b)(6).

• Brand Name: EUFLEXXA 10MG/ML SYRINGE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING / BIO - TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 9279492
• MDR Text Key: 165273047
• Report Number: MW5090867
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566410001
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/28/2020
• Device Lot Number: P14216A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR