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

Model Number SOP40KARID

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 02/17/2018

Event Type  malfunction  

Event 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.

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
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): SC003 SC-FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• Manufacturer (Section G): SC003 SC-FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 7506454
• MDR Text Key: 108005015
• Report Number: 1423537-2018-00199
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10887488826073
• UDI-Public: 10887488826073
• 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,user faci
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: SOP40KARID
• Device Catalogue Number: SOP40KARID
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Weight: 113