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

Lot Number 0013D19G

Device Problem Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Urticaria (2278)

Event Date 09/04/2013

Event Type  Injury  

Event Description

On (b)(6) 2013 - (b)(6) old male pt had an injection of gel-one in his knee for osteoarthritis.About six hours later, he developed diffuse itching, nausea, and flushing.In his words, "my whole body was a welt".He called the surgeon who prescribed a medrol dosepak and benadryl.This helped initially and he had relatively few symptoms on saturday and sunday, on (b)(6) 2013.On (b)(6) 2013 - he began to have increase in his rash again.On (b)(6) 2013 - on the day of admission, he was having intense diffuse itching again.This was not accompanied by as much as a rash.He saw the surgeon who sent him to the hospital as a direct admission.On (b)(6) 2013 - at the time of history and physical check, he was still having diffuse itching and was in an obvious state of some agitation because of benadryl he had been using.His vital signs were follows, temperature: 96, blood pressure: 114/74, pulse: 72, respirations: 18, body mass index: (b)(6).Heent examination results were unremarkable with minimal nasal congestion.Tonsils are absent.His respirations was normal.No wheezing.I/e ratio was normal.Speech was somewhat pressured, but he is not dysenteric with conversation or with moving about during the examination.S1 and s2 ecg were normal.Rhythm was regular with no murmurs.Peripheral pulse was good.He had notable for some blanching of the skin on light pressure suggestive of generalized erythroderma.There was no induration, and the skin was not particularly warm.It appeared salmon pink over some parts of his body such as the upper portion of the chest and portions of the arms and thighs.He had notable for generalized agitation.He spoke rapidly and was anxious.This did not appear to be due to physical distress as with pain, dyspnea, nausea.He was alert and oriented and furnishes details of the present illness well and quickly.No focal neurological deficits.Coordination was normal.No resting or action tremors.Strength was not tested in detail, but seems to be normal by observation.He was discharged.

Manufacturer Narrative

This is a definitive report.(b)(4).

• Brand Name: GEL-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORP.; chiyoda-ku, tokyo 100- 0005; JA 100-0005
• Manufacturer Contact: 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0-005 ; 52208556
• MDR Report Key: 3565525
• MDR Text Key: 4052479
• Report Number: 9612392-2013-00007
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2014
• Device Lot Number: 0013D19G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/30/2013
• Device Age: 4 MO
• Event Location: Home
• Date Report to Manufacturer: 12/05/2013
• Date Manufacturer Received: 12/06/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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
• Treatment: COLCHICINE; NASACORT AQ; KETOCONAZOLE 2% TOPICAL CREAM; MULTIVITAMIN WITH MINERALS; GLUCOSAMINE; ASPIRIN; SIMVASTATIN; VIAGRA; MIRALAX; FLUOXETINE; GEMFIBROZIL; FISH OIL
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 94