MAUDE Adverse Event Report: FIDIA HYALGAN

Lot Number 150900

Device Problem Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Pain (1994); Skin Discoloration (2074); Burning Sensation (2146); Tingling (2171); Complaint, Ill-Defined (2331); Reaction (2414)

Event Date 07/18/2016

Event Type  Injury  

Event Description

(b)(6).Adverse reaction to hyalgan knee injections lot #156100, lot #150900 chronology: (b)(6): 1st injection in left knee by dr.(b)(6), office.No reaction to this injection in the following days.On (b)(6): 2nd injection in left knee and first injection in right knee within minutes of the injections the left thigh above the knee began to tingle, 'heat' and itch with a burning sensation.The veins on the left thigh had turned dark purple and brown.The tingling and discomfort continued for several hours on the left side.The veins are permanently discolored.The night of (b)(6), i experienced a lot of reflux, indigestion and diarrhea.I also had massive knee pain in both legs; the increment in bi-lateral knee pain continued for three days.On (b)(6) i called dr.(b)(6) office and reported my reaction to the injections.I requested a call back from the doctor but did not receive one.I contacted dr.(b)(6) office and requested a copy of the "c" ticket to determine which lot had been used in the 2nd injection in the left knee but this info was not provided.On (b)(6), i called the fda and spoke to (b)(6); we began a report about this allergic response.On (b)(6), i called dr.(b)(6) office and (b)(6) gave me the lot numbers of the injections.I also wrote ms.(b)(6) of the (b)(6) office and requested the "c" copy but have no response to that request so far.On (b)(6): f/u visit with dr.(b)(6) who assured me the broken blood vessels and reaction had nothing to do with the 2nd injection of hyalgan in my left knee.He suggests it is 'psychological' and is confident he can re-inject both knees.I respond 'no', that following the horrible aspect of the veins on my left thigh i do not wish to risk even further damage.On (b)(6): i contact (b)(4), the producer of hyalgan and learned the injections were produced in (b)(4).Ms.(b)(6) recommends i contact their "medical info" line; i spoke to (b)(6), who took a full report, case #(b)(4).I told (b)(6) that when the next rep from (b)(4) calls.I would like to submit this report along with a photo of the damaged thigh.(b)(6) tells me i will be hearing from another rep from (b)(4).(b)(4).Note: dr.(b)(6), office still has 7 remaining hyalgan injections that were approved by (b)(6) for use on my knees.A total of 10 injections, 5 per knee.A total of 3 were used.Dates of use: (b)(6) 2016.Diagnosis or reason for use: to treat pain in post patellar femoral syndrome.

• Brand Name: HYALGAN
• Type of Device: HYALGAN
• Manufacturer (Section D): FIDIA
• MDR Report Key: 5888351
• MDR Text Key: 52669136
• Report Number: MW5064183
• Device Sequence Number: 2
• Product Code: MOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/19/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 150900
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 64