MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD EUFLEXXA; 1% SODIUM HYALURONATE

Catalog Number 6301182010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Arthralgia (2355); Limited Mobility Of The Implanted Joint (2671)

Event Date 06/08/2016

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Pseudosepsis [pseudosepsis]; most painful injection ever had [injection site pain]; 10-15 minutes before could bear weight on legs [weight bearing difficulty]; knees worse than ever felt [arthralgia]; mobility very limited [mobility decreased]; case description: this serious, spontaneous report was received from a consumer in the united states.This report concerns a (b)(6)-year- old female who experienced pseudosepsis, most painful injection she ever had, 10-15 minutes before she could bear weight on legs, knees worse than ever felt, and mobility very limited during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 1 %, initial injection of unknown dose, for osteoarthritis on (b)(6) 2016.On (b)(6) 2016, the patient experienced the most painful injection she ever had, 10-15 minutes before she could bear weight on legs, knees worse than ever felt, and mobility very limited.On (b)(6) 2016, the patient was diagnosed with pseudosepsis by her own doctor for which cortisone was prescribed.The event of pseudosepsis was assessed as serious due to criterion of medically significant.All other events were assessed as non-serious.Action taken with euflexxa was unknown.The event of pseudosepsis, arthralgia, and mobility decreased were not resolved.The events of injection site pain and weight bearing difficulty were resolved (date unknown).Concomitant medication was not reported.The patient`s past drug therapy was significant for synvisc (hylan g-f 20).Additional medical history was not reported.At the time of reporting, the case outcome was not recovered.Initial report received on 08-jun-2016 was assessed as non-serious with receipt date of 07-jun-2016.Additional information was received on 09-jun-2016 which upgraded report to serious with initial receipt date of 08-jun-2016.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: (b)(4).

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Pseudosepsis [pseudosepsis].Most painful injection ever had [injection site pain].(ten - fifteen) 10-15 minutes before could bear weight on legs [weight bearing difficulty].Knees worse than ever felt [arthralgia].Mobility very limited [mobility decreased].Case description: this serious, spontaneous report was received from a consumer in the united states.This report concerns a (b)(6) female who experienced pseudosepsis, most painful injection she ever had, 10-15 minutes before she could bear weight on legs, knees worse than ever felt, and mobility very limited during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 1 %, initial injection of unknown dose, for osteoarthritis on (b)(6) 2016.On (b)(6) 2016, the patient experienced the most painful injection she ever had, 10-15 minutes before she could bear weight on legs, knees worse than ever felt, and mobility very limited.On (b)(6) 2016, the patient was diagnosed with pseudosepsis by her own doctor for which cortisone was prescribed.The event of pseudosepsis was assessed as serious due to criterion of medically significant.All other events were assessed as non-serious.Action taken with euflexxa was unknown.The event of pseudosepsis, arthralgia, and mobility decreased were not resolved.The events of injection site pain and weight bearing difficulty were resolved (date unknown).Concomitant medication was not reported.The patient`s past drug therapy was significant for synvisc (hylan g-f 20).Additional medical history was not reported.At the time of reporting, the case outcome was not recovered.Initial report received on 08-jun-2016 was assessed as non-serious with receipt date of 07-jun-2016.Additional information was received on 09-jun-2016 which upgraded report to serious with initial receipt date of 08-jun-2016.Follow-up was received on 29-jun-2016: patient history updated, action taken with suspect medication updated, concomitant medication added, event outcomes updated, and narrative updated.Overall listedness (core label) is listed.Reporter causality: related.Company causality: related.Other case numbers: (b)(4).

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 5738007
• MDR Text Key: 47827262
• Report Number: 3000164186-2016-00011
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/06/2016

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 Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 06/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2016
• 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): Other
• Patient Age: 73 YR
• Patient Weight: 90