HYALGAN
Report
- Report Number
- 9610200-2017-00003
- Event Type
- Injury
- Date Received
- June 30, 2017
- Report Date
- September 25, 2017
- Manufacturer
- FIDIA FARMACEUTICI S.P.A.
- Product Code
- MOZ
- PMA / PMN Number
- P950027
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
EXEMPTION NUMBER E2011017 ON 28 NOVEMBER 2011, THE FDA GRANTED THE PERMISSION FOR THE MANUFACTURER FIDIA FARMACEUTICI (B)(4) TO SUBMIT A SINGLE MDR FOR ADVERSE EVENTS THAT INVOLVE MEDICAL DEVICES MANUFACTURED BY (B)(4) AND IMPORTED INTO THE USA BY (B)(4). (B)(4). THE PRESENT MDR REPORT SATISFIES THE REPORTING OBLIGATIONS FOR BOTH COMPANIES. THE CASE COMES FROM (B)(4) (THE FIDIA'S PARTNER IN USA) AND IT IS RELATED TO THE PRODUCT HYALGAN. THE PATIENT AFTER USING THE PRODUCT HAD INJECTION SITE JOINT PAIN AND INJECTION SITE JOINT INFECTION. THE CASE HAS BEEN DEEMED SERIOUS DUE TO MEDICAL IMPORTANT EVENT AND EXPECTED SINCE THE REACTIONS INJECTION SITE JOINT PAIN AND INJECTION SITE JOINT INFECTION ARE LISTED IN THE PACKAGE INSERT LEAFLET OF THE PRODUCT. JOINT INFECTION COULD HAVE BEEN CAUSED BY A WRONG ADMINISTRATION TECHNIQUE. IN ORDER TO EXCLUDE A PRODUCT CONTAMINATION, SQA IS REQUESTED TO PERFORM AN ADEQUATE ANALYSIS ON THE INVOLVED BATCH. THE CAUSALITY RELATIONSHIP HAS BEEN DEEMED AS PROBABLE. NO NEW SIGNAL ALERT HAS BEEN DETECTED. DEVICE WAS NOT AVAILABLE.
THIS IS A SPONTANEOUS SERIOUS CASE EMAILED FROM PHYSICIAN'S OFFICE TO FIDIA PHARMA SALES REP, FOR A (B)(6) FEMALE PATIENT. ACCORDING TO THE EMAIL COMMUNICATION: "(B)(6) FEMALE PATIENT COMPLETED 2ND HYALGAN INJECTION ON (B)(6) 2017. A FAMILY MEMBER CONTACTED OUR OFFICE ON (B)(6) 2017 WITH COMPLAINTS OF INCREASED KNEE PAIN, PRIMARILY ON THE POSTERIOR. AT THAT TIME, NO OTHER SYMPTOMS SUGGESTING INFECTION. FAMILY MEMBER WAS ADVISED OF SIGNS/SYMPTOMS OF INFECTION AND APPARENTLY PRESENTED TO TRIDENT WITH WORSENING SYMPTOMS OVER THE WEEKEND. THERE WAS COPIOUS AMOUNTS OF PURULENT FLUID DRAINED FROM HER L KNEE, AND SHE ULTIMATELY HAD TO HAVE JOINT CLEANED OUT BY ORTHOPAEDIC SURGEON. I DON'T HAVE MUCH IN THE WAY OF LAB RESULTS TO SHARE WITH YOU AT THIS TIME, AND DR. (B)(6) IS WAITING TO HEAR BACK FROM THE INFECTIOUS DISEASE DOC WORKING THIS CASE. IT WAS SUGGESTED BY INFECTIOUS DISEASE THAT WE LOOK INTO THE LOT# OF HA USED TO ENSURE NO OTHER REPORTS OF SIMILAR PROBLEMS IN PATIENTS USING THIS SAME LOT#. AS OF RIGHT NOW, NO OTHER CASES REPORTED FROM OUR PATIENT POPULATION. WE DID MULTIPLE HA INJECTIONS ON (B)(6) 2017, AS DID OTHER PHYSICIANS IN OFFICE. "
EXEMPTION NUMBER E2011017. ON 28 NOVEMBER 2011, THE FDA GRANTED THE PERMISSION FOR THE MANUFACTURER FIDIA FARMACEUTICI S.P.A. TO SUBMIT A SINGLE MDR FOR ADVERSE EVENTS THAT INVOLVE MEDICAL DEVICES MANUFACTURED BY FIDIA FARMACEUTICI S.P.A. AND IMPORTED INTO THE USA BY FIDIA PHARMA USA, INC. AS A CONSEQUENCE, FIDIA FARMACEUTICI S.P.A. (THE MANUFACTURER) IS SUBMITTING THIS REPORT EVEN ON BEHALF OF FIDIA PHARMA USA INC. (THE IMPORTER). THE PRESENT MDR REPORT SATISFIES THE REPORTING OBLIGATIONS FOR BOTH COMPANIES. THE CASE COMES FROM FIDIA PHARMA USA (THE FIDIA'S PARTNER IN USA) AND IT IS RELATED TO THE PRODUCT HYALGAN. THE PATIENT AFTER USING THE PRODUCT HAD INJECTION SITE JOINT PAIN AND INJECTION SITE JOINT INFECTION. THE CASE HAS BEEN DEEMED SERIOUS DUE TO MEDICAL IMPORTANT EVENT AND EXPECTED SINCE THE REACTIONS INJECTION SITE JOINT PAIN AND INJECTION SITE JOINT INFECTION ARE LISTED IN THE PACKAGE INSERT LEAFLET OF THE PRODUCT. JOINT INFECTION COULD HAVE BEEN CAUSED BY A WRONG ADMINISTRATION TECHNIQUE. IN ORDER TO EXCLUDE A PRODUCT CONTAMINATION, SQA IS REQUESTED TO PERFORM AN ADEQUATE ANALYSIS ON THE INVOLVED BATCH. THE CAUSALITY RELATIONSHIP HAS BEEN DEEMED AS PROBABLE. NO NEW SIGNAL ALERT HAS BEEN DETECTED. FOLLOW-UP INFORMATION (05-JUL-2017): THE FU COMES FROM FIDIA US. THE CASE HAS BEEN UPDATED WITH THE NEW SAFETY INFORMATION. THE SERIOUSNESS CRITERION HOSPITALIZATION HAS BEEN ADDED. THE LABORATORY TEST ON HYALGAN SAMPLE WAS PERFORMED BY THE PHYSICIAN AND NO GROWTH WAS FOUND. THE CASE HAS BEEN CONFIRMED BY THE PHYSICIAN, THUS IT WILL BE ALSO NOTIFIED VIA EUDRAVIGILANCE TO MHRA. THE CASE REMAINS SERIOUS/LISTED. NO NEW SIGNAL ALERT HAS BEEN DETECTED. WE ARE WAITING FOR THE RESULTS FROM OUR QA DEPT. ON THE SAMPLE FROM ARCHIVE. DEVICE WAS NOT AVAILABLE.
EXEMPTION NUMBER E2011017ON 28 NOVEMBER 2011, THE FDA GRANTED THE PERMISSION FOR THE MANUFACTURER FIDIA FARMACEUTICI S.P.A. TO SUBMIT A SINGLE MDR FOR ADVERSE EVENTS THAT INVOLVE MEDICAL DEVICES MANUFACTURED BY FIDIA FARMACEUTICI S.P.A. AND IMPORTED INTO THE USA BY FIDIA PHARMA USA, INC. AS A CONSEQUENCE, FIDIA FARMACEUTICI S.P.A. (THE MANUFACTURER) IS SUBMITTING THIS REPORT EVEN ON BEHALF OF FIDIA PHARMA USA INC. (THE IMPORTER). THE PRESENT MDR REPORT SATISFIES THE REPORTING OBLIGATIONS FOR BOTH COMPANIES.THE CASE COMES FROM FIDIA PHARMA USA (THE FIDIA'S PARTNER IN USA) AND IT IS RELATED TO THE PRODUCT HYALGAN. THE PATIENT AFTER USING THE PRODUCT HAD INJECTION SITE JOINT PAIN AND INJECTION SITE JOINT INFECTION. THE CASE HAS BEEN DEEMED SERIOUS DUE TO MEDICAL IMPORTANT EVENT AND EXPECTED SINCE THE REACTIONS INJECTION SITE JOINT PAIN AND INJECTION SITE JOINT INFECTION ARE LISTED IN THE PACKAGE INSERT LEAFLET OF THE PRODUCT. JOINT INFECTION COULD HAVE BEEN CAUSED BY A WRONG ADMINISTRATION TECHNIQUE. IN ORDER TO EXCLUDE A PRODUCT CONTAMINATION, SQA IS REQUESTED TO PERFORM AN ADEGUATE ANALYSIS ON THE INVOLVED BATCH. THE CAUSALITY RELATIONSHIP HAS BEEN DEEMED AS PROBABLE. NO NEW SIGNAL ALERT HAS BEEN DETECTED.FOLLOW-UP INFORMATION (05-JUL-2017):THE FU COMES FROM FIDIA US. THE CASE HAS BEEN UPDATED WITH THE NEW SAFETY INFORMATION. THE SERIOUSNESS CRITERION HOSPITALIZATION HAS BEEN ADDED. THE LABORATORY TEST ON HYALGAN SAMPLE WAS PERFORMED BY THE PHYSICIAN AND NO GROWHT WAS FOUND.THE CASE HAS BEEN CONFIRMED BY THE PHYSICIAN, THUS IT WILL BE ALSO NOTIFIED VIA EUDRAVIGILANCE TO MHRA. THE CASE REMAINS SERIOUS/LISTED. NO NEW SIGNAL ALERT HAS BEEN DETECTED. WE ARE WAITING FOR THE RESULTS FROM OUR QA DEPT. ON THE SAMPLE FROM ARCHIVE.FOLLOW-UP INFORMATION (07-SEP-2017):THE FOLLOW-UP VERSION HAS BEEN CREATED IN ORDER TO COMUNICATE THAT THE BATCH ANALYSIS PERFORMED FROM OUR QA DEPT. ON THE SAMPLE FROM ARCHIVE, SHOWED THERE WERE NO QUALITY ISSUES ON THE PRODUCT WHICH WAS COMPLAINT WITH THE SPECIFICATIONS.
THIS IS A SPONTANEOUS SERIOUS CASE EMAILED FROM PHYSICIAN'S OFFICE TO FIDIA PHARMA SALES REP, FOR A (B)(6) YEAR OLD FEMALE PATIENT. ACCORDING TO THE EMAIL COMMUNICATION: "(B)(6) YEAR OLD FEMALE PATIENT COMPLETED 2ND HYALGAN INJECTION ON (B)(6) 2017. A FAMILY MEMBER CONTACTED OUR OFFICE ON (B)(6) 2017 WITH COMPLAINTS OF INCREASED KNEE PAIN, PRIMARILY ON THE POSTERIOR. AT THAT TIME, NO OTHER SYMPTOMS SUGGESTING INFECTION. FAMILY MEMBER WAS ADVISED OF SIGNS/SYMPTOMS OF INFECTION AND APPARENTLY PRESENTED TO TRIDENT WITH WORSENING SYMPTOMS OVER THE WEEKEND. THERE WAS COPIOUS AMOUNTS OF PURULENT FLUID DRAINED FROM HER L KNEE, AND SHE ULTIMATELY HAD TO HAVE JOINT CLEANED OUT BY ORTHOPAEDIC SURGEON. I DON'T HAVE MUCH IN THE WAY OF LAB RESULTS TO SHARE WITH YOU AT THIS TIME, AND DR. (B)(6) IS WAITING TO HEAR BACK FROM THE INFECTIOUS DISEASE DOC WORKING THIS CASE. IT WAS SUGGESTED BY INFECTIOUS DISEASE THAT WE LOOK INTO THE LOT# OF HA USED TO ENSURE NO OTHER REPORTS OF SIMILAR PROBLEMS IN PATIENTS USING THIS SAME LOT#. AS OF RIGHT NOW, NO OTHER CASES REPORTED FROM OUR PATIENT POPULATION. WE DID MULTIPLE HA INJECTIONS ON (B)(6) 2017 AND (B)(6) 2017, AS DID OTHER PHYSICIANS IN OFFICE." FOLLOW-UP INFORMATION (05-JUL-2017): REPEATED CALLS WERE MADE TO THE PHYSICIAN'S OFFICE FOR ADDITIONAL INFORMATION. PHYSICIAN CONTACTED (B)(4) (B)(6) 2017 AND REPORTED THE PATIENT HAD BEEN IN THE HOSPITAL FOR APPROXIMATELY FOUR DAYS AND DISCHARGED, MONDAY OR TUESDAY ((B)(6) 2017) AFTER UNDERGOING AN EMERGENCY IRRIGATION AND DEBRIDEMENT OF THE LEFT KNEE AFTER HER SECOND INJECTION OF HYALGAN. THE PHYSICIAN STATED THAT THE PATIENT WILL REMAIN ON IV ANTIBIOTICS, UNSPECIFIED, FOR SEVERAL WEEKS BUT WAS DOING WELL. THE PHYSICIAN REPORTED THAT THE PATIENT HAD UNDERGONE RECENT SKIN PROCEDURES TO HAVE SKIN LESIONS EXCISED. THE PHYSICIAN REPORTED THE PATIENT'S LEG WAS RED AND COULD HAVE SLOUGHED AND AFFECTED HER KNEE. A SAMPLE SYRINGE OF THE SAME LOT NUMBER WAS SUBMITTED TO THE LAB FOR TESTING. A REQUEST WAS MADE BY FIDIA TO OBTAIN ADDITIONAL PATIENT INFORMATION FOR THIS CASE. THE PHYSICIAN STATED HE WOULD LEAVE A MESSAGE WITH HIS ASSISTANT IN ORDER TO OBTAIN THE INFORMATION ON MONDAY (B)(6) 2017. THE PHYSICIAN'S OFFICE WAS CONTACTED ON (B)(6) 2017. ON (B)(6) 2017 THE PHYSICIAN'S ASSISTANT RETURNED (B)(4)'S CALL. IT WAS REPORTED THAT THE PATIENT CONTACTED THE PHYSICIAN'S OFFICE ON (B)(6) 2017 STATING SHE HAD INCREASED LEFT KNEE PAIN POST INJECTION. AT THAT TIME THERE WERE NO SIGNS OF FEVER OR INFECTION. THE FOLLOWING DAY (B)(6) 2017 THE PATIENT WENT TO THE HOSPITAL AND REQUIRED SURGERY, IRRIGATION AND DEBRIDEMENT OF LEFT SEPTIC KNEE'. NO DETAILS OF FLUID EVALUATION AND TESTING WERE PROVIDED. THE PHYSICIAN'S ASSISTANT WAS THEN REQUESTED TO PROVIDE FURTHER PATIENT INFORMATION SUCH AS KNOWN MEDICAL HISTORY. THE ASSISTANT REFUSED TO PROVIDE ANY INFORMATION STATING HIPAA.
THIS IS A SPONTANEOUS SERIOUS CASE EMAILED FROM PHYSICIAN'S OFFICE TO FIDIA PHARMA SALES REP, FOR A (B)(6) FEMALE PATIENT. ACCORDING TO THE EMAIL COMMUNICATION: "(B)(6) FEMALE PATIENT COMPLETED 2ND HYALGAN INJECTION ON (B)(6) 2017. A FAMILY MEMBER CONTACTED OUR OFFICE ON 6/9/17 WITH COMPLAINTS OF INCREASED KNEE PAIN, PRIMARILY ON THE POSTERIOR. AT THAT TIME, NO OTHER SYMPTOMS SUGGESTING INFECTION. FAMILY MEMBER WAS ADVISED OF SIGNS/SYMPTOMS OF INFECTION AND APPARENTLY PRESENTED TO TRIDENT WITH WORSENING SYMPTOMS OVER THE WEEKEND. THERE WAS COPIOUS AMOUNTS OF PURULENT FLUID DRAINED FROM HER L KNEE, AND SHE ULTIMATELY HAD TO HAVE JOINT CLEANED OUT BY ORTHOPAEDIC SURGEON. I DON'T HAVE MUCH IN THE WAY OF LAB RESULTS TO SHARE WITH YOU AT THIS TIME, AND DR. HULVEY IS WAITING TO HEAR BACK FROM THE INFECTIOUS DISEASE DOC WORKING THIS CASE. IT WAS SUGGESTED BY INFECTIOUS DISEASE THAT WE LOOK INTO THE LOT# OF HA USED TO ENSURE NO OTHER REPORTS OF SIMILAR PROBLEMS IN PATIENTS USING THIS SAME LOT#. AS OF RIGHT NOW, NO OTHER CASES REPORTED FROM OUR PATIENT POPULATION. WE DID MULTIPLE HA INJECTIONS ON (B)(6) 2017 AND (B)(6) 2017, AS DID OTHER PHYSICIANS IN OFFICE." FOLLOW-UP INFORMATION (05-JUL-2017): REPEATED CALLS WERE MADE TO THE PHYSICIAN'S OFFICE FOR ADDITIONAL INFORMATION. PHYSICIAN CONTACTED FIDIA 16-JUN-2017 AND REPORTED THE PATIENT HAD BEEN IN THE HOSPITAL FOR APPROXIMATELY FOUR DAYS AND DISCHARGED, MONDAY OR TUESDAY ((B)(6) 2017) AFTER UNDERGOING AN EMERGENCY IRRIGATION AND DEBRIDEMENT OF THE LEFT KNEE AFTER HER SECOND INJECTION OF HYALGAN. THE PHYSICIAN STATED THAT THE PATIENT WILL REMAIN ON IV ANTIBIOTICS, UNSPECIFIED, FOR SEVERAL WEEKS BUT WAS DOING WELL. THE PHYSICIAN REPORTED THAT THE PATIENT HAD UNDERGONE RECENT SKIN PROCEDURES TO HAVE SKIN LESIONS EXCISED. THE PHYSICIAN REPORTED THE PATIENT'S LEG WAS RED AND COULD HAVE SLOUGHED AND AFFECTED HER KNEE. A SAMPLE SYRINGE OF THE SAME LOT NUMBER WAS SUBMITTED TO THE LAB FOR TESTING. A REQUEST WAS MADE BY FIDIA TO OBTAIN ADDITIONAL PATIENT INFORMATION FOR THIS CASE. THE PHYSICIAN STATED HE WOULD LEAVE A MESSAGE WITH HIS ASSISTANT IN ORDER TO OBTAIN THE INFORMATION ON MONDAY 19-JUN-2017. THE PHYSICIAN'S OFFICE WAS CONTACTED ON 1-JUN-2017. ON 23-JUN-2017 THE PHYSICIAN'S ASSISTANT RETURNED FIDIA'S CALL. IT WAS REPORTED THAT THE PATIENT CONTACTED THE PHYSICIAN'S OFFICE ON 09-JUN-2017 STATING SHE HAD INCREASED LEFT KNEE PAIN POST INJECTION. AT THAT TIME THERE WERE NO SIGNS OF FEVER OR INFECTION. (B)(6) 2017 THE PATIENT WENT TO THE HOSPITAL AND REQUIRED SURGERY, IRRIGATION AND DEBRIDEMENT OF LEFT SEPTIC KNEE'. NO DETAILS OF FLUID EVALUATION AND TESTING WERE PROVIDED. THE PHYSICIAN'S ASSISTANT WAS THEN REQUESTED TO PROVIDE FURTHER PATIENT INFORMATION SUCH AS KNOWN MEDICAL HISTORY. THE ASSISTANT REFUSED TO PROVIDE ANY INFORMATION STATING HIPAA. FOLLOW-UP 2 INFORMATION (07-SEP-2017): AFTER BATCH ANALYSIS ON HYALGAN 20MG/2ML SOLUTION FOR INJECTION (HYALURONATE SODIUM; BATCH NO: A00330) NO QUALITY ISSUES WERE HIGHLIGHTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 463911 | HYALGAN | SODIUM HYALURONATE | MOZ | FIDIA FARMACEUTICI S.P.A. | A00330 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Other |