MAUDE Adverse Event Report: FERRING EUFLEXXA

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Erythema (1840); Itching Sensation (1943); Rash (2033); Swelling (2091); Abdominal Distention (2601); Weight Changes (2607)

Event Date 01/02/2017

Event Type  Injury  

Event Description

Caller reported that she received three shots of euflexxa one week apart.She developed a breakout of rash, itching redness and swelling.She went to her dermatologist who could not explain the cause of her symptoms.She was finally diagnosed with lymphedema by an infectious disease doctor and she will soon begin treatment.Caller also reported that she found information online that suggests that her symptoms were caused by euflexxa.Also that she has gained (b)(6) and her abdomen is distended.

• Brand Name: EUFLEXXA
• Type of Device: EUFLEXXA
• Manufacturer (Section D): FERRING
• MDR Report Key: 6666593
• MDR Text Key: 78458243
• Report Number: MW5070600
• Device Sequence Number: 1
• Product Code: MOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2017

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 77