MAUDE Adverse Event Report: SC003 SC-FORT MILL DOCX HBS BREAST AUGMENTATION (BASHJ)981; GENERAL SURGERY TRAY (KIT)

Model Number	SBA16BASHK
Health Effect - Clinical Code	Erythema (1840)
Date of Event	01/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on supplier investigation, the device history record could not be reviewed as lot number was not provided.After supplier review of process/procedure it was confirmed there is a proper gowning requirement and environmental controls in place.There was no change in raw material and process for these products.They reviewed the skin irritation test report and the raw material shall be excluded from impacted items.A sample was not available for further investigation, so the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer informed cardinal health that approximately a week after inframammary breast augmentation, a female patient developed redness of both lower breasts without fever where such redness is extremely unusual.Doctor was unable to culture breasts since it would require going back to surgery, so patient was started on antibiotics.The course of antibiotics was lengthened by infectious disease doctor.Customer is wondering if this issue is in conjunction with the gown recall.This case used a cardinal health breast augmentation pack sba16bashk that contained aami level 3 gown 9548ncb and 9518ncb.No sample was available for evaluation and a work order/lot number was not provided for the kit, therefore, we are unable to confirm that the gown in the kit was part of the recall issued by cardinal health.The patient is now fine with no signs of infection.

• Brand Name: DOCX HBS BREAST AUGMENTATION (BASHJ)981
• 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: 9742187
• Report Number: 1423537-2020-00425
• Device Sequence Number: 1802433
• Product Code: LRO
• UDI-Device Identifier: 10888439350579
• UDI-Public: 10888439350579
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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: Health Professional
• Device Model Number: SBA16BASHK
• Device Catalogue Number: SBA16BASHK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/21/2020
• 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 Weight: 50