MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE; ACID, HYALURONIC, INTRAARTICULAR

Model Number 00-1111-001-00

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Swelling (2091); Reaction (2414)

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

This is a definitive report.There were no deviations or out-of-specifications found in the manufacturing process, the in-process testing, the release testing, and the environmental monitoring for lot.No.0015g21g.Manufacturer assured that there was no quality problem on the identified product batch (lot no.0015g21g).Our medical advisor's comment is as follows: it is possible that gel-one caused injection site joint swelling and injection site joint redness, since these developed the day after the administration.Intraarticular hemorrhage is considered to have been developed due to an administration procedure or an injury and it is negative that gel-one caused that.In terms of seriousness of these events, those events are considered to be not serious, since the treatment for them was only drainage of synovial fluid.(b)(4).

Event Description

On (b)(6) 2015 - a (b)(6) male patient had injection of gel-one to the left knee for osteoarthritis.Prior to using gel-one, he had a tibial fracture, and he was already in a state of injury before the product was used.On (b)(6) 2015 - he began having a serious reaction, including swelling, redness and bleeding 8 hours after using the product at the pharmacy.On (b)(6) 2015 - he did have to return to the pharmacy, where the doctor drained the affected area.He took metro dose pack for inflammation.This did not cause the patient any persistent or significant disability/incapacity, as the patient got better throughout the week.On (b)(6) 2016 - the doctor stated he was going to see the patient again this week, but does not expect any further issues since the patient was doing better.

• Brand Name: GEL-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku , tokyo, 100-0 005; JA 100-0005
• Manufacturer (Section G): SEIKAGAKU CORPORATION; takahagi plant; 258-5, aza-matsukubo; oaza-akahama, takahagi-shi, ibaraki 318-0 001; JA 318-0001
• Manufacturer Contact: pharmacovigilance dept. ; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo, 100-0-005 ; JA 100-0005 ; 353 208556
• MDR Report Key: 5377646
• MDR Text Key: 36339273
• Report Number: 9612392-2016-00001
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/24/2015,12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2016
• Device Model Number: 00-1111-001-00
• Device Catalogue Number: 00-1111-001-00
• Device Lot Number: 0015G21G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/21/2015
• Device Age: 4 MO
• Date Report to Manufacturer: 12/24/2015
• Date Manufacturer Received: 12/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• 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: 56 YR