HYALGAN
Report
- Report Number
- 9610200-2016-00007
- Event Type
- Injury
- Date Received
- September 1, 2016
- Report Date
- October 10, 2016
- Manufacturer
- FIDIA FARMACEUTICI S.P.A.
- Product Code
- MOZ
- PMA / PMN Number
- P950027
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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 WAS RECEIVED FROM FIDIA PHARMA USA (THE FIDIA'S PARTNER IN USA). THE ADVERSE REACTION "INJECTION SITE JOINT INFECTION" IS EXPECTED FOR HYALGAN. THE ADVERSE REACTION "OFF LABEL USE" IS UNEXPECTED FOR HYALGAN. THE CASE HAS BEEN ASSESSED AS "SERIOUS". THE RELATIONSHIP BETWEEN HYALGAN AND THE EVENT WAS DEEMED AS BEING "PROBABLE" FOR THE "INJECTION SITE JOINT INFECTION". FIDIA STARTED ITS INVESTIGATIONS OF THE BATCHES NUMBERS INVOLVED AND WILL PROVIDE THE RESULTS ON THEM AS SOON AS AVAILABLE. FOLLOW-UP 25-AUG-2016: THE FOLLOW-UP RECEIVED ON THE 25-AUG-2016 REPORTED NEW SAFETY INFORMATION. THE GENDER OF THE PATIENT HAS BEEN CHANGED FROM FEMALE TO MALE. THE INJECTION SITE HAS BEEN CHANGED FROM WRIST TO FINGER. THE CAUSALITY OF THE INFECTION IN THE INJECTION SITE REACTION IS DOWNGRADED TO POSSIBLE BECAUSE THE LAB TEST WAS NEGATIVE. THE NEW ADVERSE EVENT REPORTED ARE: INJECTION SITE SWELLING AND TENDON INJURY. THE "INJECTION SITE SWELLING" IS EXPECTED FOR HYALGAN WHILE "TENDON INJURY" IS UNEXPECTED. THE RELATIONSHIP BETWEEN HYALGAN AND THE EVENT WAS DEEMED AS BEING "PROBABLE" FOR THE "INJECTION SITE SWELLING", AND "POSSIBLE" FOR THE "TENDON INJURY". THE BATCHES NUMBERS INVOLVED IN THE CASE WERE VERIFIED BY THE FIDIA QUALITY ASSURANCE DEPARTMENT AND THE WRONG EXPIRATION DATES REPORTED IN THE NARRATIVE HAVE BEEN CORRECTED. IN PARTICULAR THE BATCH NUMBER (B)(4) EXPIRATION DATE 08-NOV-2018; AND 155900 EXPIRATION DATE 10-DEC-2018. THE COMPANY IS PERFORMING AN ADEQUATE INVESTIGATION ON THE BATCH OF THE PRODUCT INVOLVED IN THE OCCURRENCE. A FURTHER FU HAS BEEN SCHEDULED AND IF THERE WILL BE NEW SAFETY INFORMATION ON THE CASE IT WILL BE COMMUNICATED. FOLLOW-UP 08-SEP-2016: THE FOLLOW-UP INFORMATION CONFIRMED THE FINGER AS SITE OF THE INFECTION AND CONFIRMED THE STAPH INFECTION. THUS THE RELATIONSHIP BETWEEN THE REACTIONS "INJECTION SITE JOINT INFECTION AND TENDON INJURY" AND THE ADMINISTRATION OF HYALGAN IS DEEMED AS BEING "PROBABLE" BECAUSE THE INJECTION SITE JOINT INFECTION HAS BEEN CONFIRMED BY HCP AND THE TENDON INJURY WAS STATED TO BE RELATED THE INJECTION SITE JOINT INFECTION BY THE PATIENT. IN ACCORDANCE WITH OUR INTERNAL PROCEDURE, THE QUALITY ASSURANCE DEPARTMENT PERFORMED A DEEP EVALUATION OF PRODUCTION AND QUALITY CONTROL DOCUMENTATION. FROM THIS EVALUATION NO ANOMALY WAS FOUND. IN PARTICULAR, NO DEVIATION OR PROBLEM WERE DETECTED DURING THE MANUFACTURING PROCESS, ALL RESULTS ARE IN ACCORDANCE WITH THE SPECIFICATION AND NO ANOMALOUS TREND WAS IDENTIFIED. ON THE BASIS OF THE INVESTIGATION PERFORMED ON DOCUMENTATION NO ANOMALY WAS FOUND AND THERE IS NOT A PRODUCT QUALITY ISSUE THAT COULD BE RELATED TO THE EVENTS DESCRIBED IN THE DEFECT DESCRIPTION. DEVICE WAS NOT AVAILABLE.
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 WAS RECEIVED FROM FIDIA PHARMA USA (THE FIDIA'S PARTNER IN USA). THE ADVERSE REACTION "INJECTION SITE JOINT INFECTION" IS EXPECTED FOR HYALGAN. THE ADVERSE REACTION "OFF LABEL USE" IS UNEXPECTED FOR HYALGAN. THE CASE HAS BEEN ASSESSED AS "SERIOUS". THE RELATIONSHIP BETWEEN HYALGAN AND THE EVENT WAS DEEMED AS BEING "PROBABLE" FOR THE "INJECTION SITE JOINT INFECTION". FIDIA STARTED ITS INVESTIGATIONS OF THE BATCHES NUMBERS INVOLVED AND WILL PROVIDE THE RESULTS ON THEM AS SOON AS AVAILABLE. DEVICE WAS NOT AVAILABLE.
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 WAS RECEIVED FROM FIDIA PHARMA USA (THE FIDIA'S PARTNER IN USA). THE ADVERSE REACTION "INJECTION SITE JOINT INFECTION" IS EXPECTED FOR HYALGAN. THE ADVERSE REACTION "OFF LABEL USE" IS UNEXPECTED FOR HYALGAN. THE CASE HAS BEEN ASSESSED AS "SERIOUS". THE RELATIONSHIP BETWEEN HYALGAN AND THE EVENT WAS DEEMED AS BEING "PROBABLE" FOR THE "INJECTION SITE JOINT INFECTION". FIDIA STARTED ITS INVESTIGATIONS OF THE BATCHES NUMBERS INVOLVED AND WILL PROVIDE THE RESULTS ON THEM AS SOON AS AVAILABLE. FOLLOW-UP 25-AUG-2016: THE FOLLOW-UP RECEIVED ON THE 25-AUG-2016 REPORTED NEW SAFETY INFORMATION. THE GENDER OF THE PATIENT HAS BEEN CHANGED FROM FEMALE TO MALE. THE INJECTION SITE HAS BEEN CHANGED FROM WRIST TO FINGER. THE CAUSALITY OF THE INFECTION IN THE INJECTION SITE REACTION IS DOWNGRADED TO POSSIBLE BECAUSE THE LAB TEST WAS NEGATIVE. THE NEW ADVERSE EVENT REPORTED ARE: INJECTION SITE SWELLING AND TENDON INJURY. THE "INJECTION SITE SWELLING" IS EXPECTED FOR HYALGAN WHILE "TENDON INJURY" IS UNEXPECTED. THE RELATIONSHIP BETWEEN HYALGAN AND THE EVENT WAS DEEMED AS BEING "PROBABLE" FOR THE "INJECTION SITE SWELLING", AND "POSSIBLE" FOR THE "TENDON INJURY". THE BATCHES NUMBERS INVOLVED IN THE CASE WERE VERIFIED BY THE FIDIA QUALITY ASSURANCE DEPARTMENT AND THE WRONG EXPIRATION DATES REPORTED IN THE NARRATIVE HAVE BEEN CORRECTED. IN PARTICULAR THE BATCH NUMBER 1555000 EXPIRATION DATE 08-NOV-2018; AND 155900 EXPIRATION DATE 10-DEC-2018. THE COMPANY IS PERFORMING AN ADEQUATE INVESTIGATION ON THE BATCH OF THE PRODUCT INVOLVED IN THE OCCURRENCE. A FURTHER FU HAS BEEN SCHEDULED AND IF THERE WILL BE NEW SAFETY INFORMATION ON THE CASE IT WILL BE COMMUNICATED. FOLLOW-UP 08-SEP-2016: THE FOLLOW-UP INFORMATION CONFIRMED THE FINGER AS SITE OF THE INFECTION AND CONFIRMED THE STAPH INFECTION. THUS THE RELATIONSHIP BETWEEN THE REACTIONS "INJECTION SITE JOINT INFECTION AND TENDON INJURY" AND THE ADMINISTRATION OF HYALGAN IS DEEMED AS BEING "PROBABLE" BECAUSE THE INJECTION SITE JOINT INFECTION HAS BEEN CONFIRMED BY HCP AND THE TENDON INJURY WAS STATED TO BE RELATED THE INJECTION SITE JOINT INFECTION BY THE PATIENT. IN ACCORDANCE WITH OUR INTERNAL PROCEDURE, THE QUALITY ASSURANCE DEPARTMENT PERFORMED A DEEP EVALUATION OF PRODUCTION AND QUALITY CONTROL DOCUMENTATION. FROM THIS EVALUATION NO ANOMALY WAS FOUND. IN PARTICULAR, NO DEVIATION OR PROBLEM WERE DETECTED DURING THE MANUFACTURING PROCESS, ALL RESULTS ARE IN ACCORDANCE WITH THE SPECIFICATION AND NO ANOMALOUS TREND WAS IDENTIFIED. ON THE BASIS OF THE INVESTIGATION PERFORMED ON DOCUMENTATION NO ANOMALY WAS FOUND AND THERE IS NOT A PRODUCT QUALITY ISSUE THAT COULD BE RELATED TO THE EVENTS DESCRIBED IN THE DEFECT DESCRIPTION. FOLLOW-UP (27-SEP-2016): MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION WERE UNSUCCESSFUL. FOLLOW-UP NO AVAILABLE. THIS CASE IS CLOSED. DEVICE WAS NOT AVAILABLE.
THIS SPONTANEOUS, SERIOUS ADVERSE EVENT WAS REPORTED BY A MEDICAL OFFICE ASSISTANT CONCERNING A FEMALE PATIENT OF UNKNOWN AGE. ON AN UNKNOWN DATE THE PATIENT WAS STARTED ON HYALGAN AT AN UNKNOWN DOSE AND FREQUENCY FOR AN UNKNOWN INDICATION OF THE WRIST. ON AN UNKNOWN DATE AFTER RECEIVING HYALGAN, THE PATIENT DEVELOPED AN INFECTION AT THE SITE OF INJECTION ON THE WRIST WHICH THE PATIENT HAD TO HAVE LANCED AND DRAINED. THE INFECTION IS SUSPECTED TO BE RELATED TO A HYALGAN PRODUCT PROBLEM. THE LOT NUMBERS REPORTED WERE 1555000 OR 155900 AND THE EXPIRATION DATES WERE REPORTED AS 11-AUG-2018 OR 12-OCT-2010 RESPECTIVELY. AS OF 08-AUG-2016 IT WAS UNKNOWN WHETHER THE PATIENT CONTINUED ON HYALGAN AND THE OUTCOME OF OFF-LABEL USE IN THE WRIST AND INFECTION WAS UNKNOWN. ATTEMPTS TO OBTAIN FOLLOW UP INFORMATION ARE ONGOING. FOLLOW-UP RECEIVED ON 25-AUG-2016: SURGICAL TECHNICIAN REPORTED THAT ON (B)(6) 2016 A MALE PATIENT GOT 1-2 ML OF HYALGAN INJECTED INTO HIS FINGER DURING TRIGGER FINGER RELEASE SURGERY. THE PATIENT DEVELOPED AN INFECTION AND SWELLING AT THE INCISION SITE IN HIS FINGER, AND HIS TENDON WAS "SHREDDED" AND COMING THROUGH THE INCISION. THE OFFICE ATTRIBUTES THE INFECTION TO A POSSIBLE DEFECTIVE BATCH OF HYALGAN SINCE THEY HAVE USED HYALGAN BEFORE WITH OTHER PATIENTS AND HAD NO PROBLEMS. THE PATIENT RECEIVED THIS HYALGAN FROM A NEW SHIPMENT THEY HAD JUST RECEIVED. THE PATIENT RECEIVED ANTIBIOTICS BUT DID NOT IMPROVE. ON (B)(6) 2016 THE INCISION SITE WAS DRAINED AND LAB CULTURES WERE TAKEN WHICH WERE NEGATIVE FOR MOLD, YEAST, AND BACTERIA. THE PATIENT WAS REFERRED TO AN INFECTIOUS DISEASE PHYSICIAN BECAUSE HIS TENDON WAS "SHREDDED TO PIECES." THE REPORTER PROVIDED THE PRESCRIBING PHYSICIAN'S INFORMATION. THE LOT NUMBERS AND EXPIRATION DATES PREVIOUSLY PROVIDED WERE 1555000 AND AUGUST 2018, AND 155900 AND 12-OCT-2010. THE CURRENT REPORTER WAS UNABLE TO PROVIDE CONFIRMATION OF LOT NUMBERS. FOLLOW-UP WAS RECEIVED ON 08-SEP-2016: SURGICAL ASSISTANT REPORTED THE MALE PATIENT RECEIVED HYALGAN IN HIS FINGER AND DEVELOPED A STAPH INFECTION THAT WAS NOT HEALING WITH ANTIBIOTICS. THE PATIENT WAS THEREFORE REFERRED TO AN INFECTIOUS DISEASE SPECIALIST. THE REPORTER STATED THAT HIS FINGER WAS "REALLY BAD". THE REPORTER DID NOT KNOW WHICH INFECTIOUS DISEASE SPECIALIST THE PATIENT VISITED AND THE PATIENT HAS NOT BEEN BACK TO THEIR OFFICE SO NO FURTHER INFORMATION IS KNOWN.
THIS SPONTANEOUS, SERIOUS ADVERSE EVENT WAS REPORTED BY A MEDICAL OFFICE ASSISTANT CONCERNING A FEMALE PATIENT OF UNKNOWN AGE. ON AN UNKNOWN DATE THE PATIENT WAS STARTED ON HYALGAN AT AN UNKNOWN DOSE AND FREQUENCY FOR AN UNKNOWN INDICATION OF THE WRIST. ON AN UNKNOWN DATE AFTER RECEIVING HYALGAN, THE PATIENT DEVELOPED AN INFECTION AT THE SITE OF INJECTION ON THE WRIST WHICH THE PATIENT HAD TO HAVE LANCED AND DRAINED. THE INFECTION IS SUSPECTED TO BE RELATED TO A HYALGAN PRODUCT PROBLEM. THE LOT NUMBERS REPORTED WERE 1555000 OR 155900 AND THE EXPIRATION DATES WERE REPORTED AS 11-AUG-2018 OR 12-OCT-2010 RESPECTIVELY. AS OF 08-AUG-2016 IT WAS UNKNOWN WHETHER THE PATIENT CONTINUED ON HYALGAN AND THE OUTCOME OF OFF-LABEL USE IN THE WRIST AND INFECTION WAS UNKNOWN. ATTEMPTS TO OBTAIN FOLLOW UP INFORMATION ARE ONGOING.
THIS SPONTANEOUS, SERIOUS ADVERSE EVENT WAS REPORTED BY A MEDICAL OFFICE ASSISTANT CONCERNING A FEMALE PATIENT OF UNKNOWN AGE. ON AN UNKNOWN DATE THE PATIENT WAS STARTED ON HYALGAN AT AN UNKNOWN DOSE AND FREQUENCY FOR AN UNKNOWN INDICATION OF THE WRIST. ON AN UNKNOWNS DATE AFTER RECEIVING HYALGAN, THE PATIENT DEVELOPED AN INFECTION AT THE SITE OF INJECTION ON THE WRIST WHICH THE PATIENT HAD TO HAVE LANCED AND DRAINED. THE INFECTION IS SUSPECTED TO BE RELATED TO A HYALGAN PRODUCT PROBLEM. THE LOT NUMBERS REPORTED WERE 1555000 OR 155900 AND THE EXPIRATION DATES WERE REPORTED AS 11-AUG-2018 OR 12-OCT-2010 RESPECTIVELY. AS OF 08-AUG-2016 IT WAS UNKNOWN WHETHER THE PATIENT CONTINUED ON HYALGAN AND THE OUTCOME OF OFF-LABEL USE IN THE WRIST AND INFECTION WAS UNKNOWN. ATTEMPTS TO OBTAIN FOLLOW UP INFORMATION ARE ONGOING. FOLLOW-UP RECEIVED ON 25-AUG-2016: SURGICAL TECHNICIAN REPORTED THAT ON (B)(6) 2016 A MALE PATIENT GOT 1-2 ML OF HYALGAN INJECTED INTO HIS FINGER DURING TRIGGER FINGER RELEASE SURGERY. THE PATIENT DEVELOPED AN INFECTION AND SWELLING AT THE INCISION SITE IN HIS FINGER, AND HIS TENDON WAS "SHREDDED" AND COMING THROUGH THE INCISION. THE OFFICE ATTRIBUTES THE INFECTION TO A POSSIBLE DEFECTIVE BATCH OF HYALGAN SINCE THEY HAVE USED HYALGAN BEFORE WITH OTHER PATIENTS AND HAD NO PROBLEMS. THE PATIENT RECEIVED THIS HYALGAN FROM A NEW SHIPMENT THEY HAD JUST RECEIVED. THE PATIENT RECEIVED ANTIBIOTICS BUT DID NOT IMPROVE. ON (B)(6) 2016 THE INCISION SITE WAS DRAINED AND LAB CULTURES WERE TAKEN WHICH WERE NEGATIVE FOR MOLD, YEAST, AND BACTERIA. THE PATIENT WAS REFERRED TO AN INFECTIOUS DISEASE PHYSICIAN BECAUSE HIS TENDON WAS "SHREDDED TO PIECES." THE REPORTER PROVIDED THE PRESCRIBING PHYSICIAN'S INFORMATION. THE LOT NUMBERS AND EXPIRATION DATES PREVIOUSLY PROVIDED WERE 1555000 AND AUGUST 2018, AND 155900 AND 12-OCT-2010. THE CURRENT REPORTER WAS UNABLE TO PROVIDE CONFIRMATION OF LOT NUMBERS. FOLLOW-UP WAS RECEIVED ON 08-SEP-2016: SURGICAL ASSISTANT REPORTED THE MALE PATIENT RECEIVED HYALGAN IN HIS FINGER AND DEVELOPED A STAPH INFECTION THAT WAS NOT HEALING WITH ANTIBIOTICS. THE PATIENT WAS THEREFORE REFERRED TO AN INFECTIOUS DISEASE SPECIALIST. THE REPORTER STATED THAT HIS FINGER WAS "REALLY BAD". THE REPORTER DID NOT KNOW WHICH INFECTIOUS DISEASE SPECIALIST THE PATIENT VISITED AND THE PATIENT HAS NOT BEEN BACK TO THEIR OFFICE SO NO FURTHER INFORMATION IS KNOWN. FOLLOW-UP (27-SEP-2016): MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION WERE UNSUCCESSFUL. FOLLOW-UP NO AVAILABLE. THIS CASE IS CLOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 572922 | HYALGAN | INTRA-ARTICULAR INJECTION | MOZ | FIDIA FARMACEUTICI S.P.A. | 1555000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |