MAUDE Adverse Event Report: SC003 SC-FORT MILL KNEE ARTHROSCOPY PACK (KARIC)575; GENERAL SURGERY TRAY (KIT)

Model Number	SOP40KARID
Health Effect - Clinical Code	Reaction (2414)
Date of Event	02/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The physician reported he had developed an allergic reaction/rash to the bilateral dorsum of the hands from something in the knee arthroscopy pack/ sop40karid believed to be caused by the specialty smart gown (b)(4).Oral and topical steroids were prescribed with good results.
Additional Manufacturer Narrative
Supplemental report is being filed since, a piece of the gown for catalog number 32474na gown specialty smartgown was returned for investigation.The stamp code on the sample is (b)(4) which indicated that the lot number as 0108am.This lot number was manufactured on 31st dec 2017 to 15th jan 2018.The device history record review did not indicate any exception that could lead to the reported incident.From the sample evaluation, there was no abnormality found.The manufacturer reviewed the record of raw material incoming inspection and it indicated that the raw material data conforms to the specification.From the investigation, the root cause could not be determined, and no further action will be taken at this time.The complaint information was provided to the relevant manufacturing sectors for their awareness and we will continue to monitor the trend of this type of incident.

• Brand Name: KNEE ARTHROSCOPY PACK (KARIC)575
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): SC003 SC-FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 7506454
• Report Number: 1423537-2018-00199
• Device Sequence Number: 11318186
• Product Code: LRO
• UDI-Device Identifier: 10887488826073
• UDI-Public: 10887488826073
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2018

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
• Operator of Device: Physician
• Device Model Number: SOP40KARID
• Device Catalogue Number: SOP40KARID
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Weight: 113