MAUDE Adverse Event Report: CARDINAL HEALTH SINGAPORE 225 PTE. LTD. AAMI 4 SMARTSLEEVE SURG GOWN LG; GOWN, SURGICAL

Model Number	9011
Health Effect - Clinical Code	Urticaria (2278)
Date of Event	01/01/1980
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record could not be verified as lot number was not provided.As sample was not returned for investigation and there is no information given on lot number, the actual supplier could not be identified.Therefore the root cause could not be determined.There is no additional action taken at this time, but we will continue to monitor the trend of this type of incident.
Event or Problem Description
The customer reported that the physician is breaking out in hives causing open lesions on the arms from the aami 4 smartsleeve surgical gown 9011.She was treated in the emergency room with iv steroids and medrol dose pack.Allergy testing was performed and showed the physician is allergic to quarternium 15.Physician is no longer wearing gown 9011 and hives have resolved.No other information was provided.The actual event date was unknown after multiple attempts to contact customer.
Additional Manufacturer Narrative
Supplemental report being filed due to the manufacturers name and address on the initial report was entered incorrectly.The correct manufacturer name and address in sections d3 and g1 is now being submitted.No other changes to the report are required.

• Brand Name: AAMI 4 SMARTSLEEVE SURG GOWN LG
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH SINGAPORE 225 PTE. LTD.; 10 kallang avenue #10-10/18; aperian TX 33951 0; SN 339510
• MDR Report Key: 9881242
• Report Number: 1423537-2020-00443
• Device Sequence Number: 16831932
• Product Code: FYA
• UDI-Device Identifier: 10885380156489
• UDI-Public: 10885380156489
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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: 9011
• Device Catalogue Number: 9011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 03/27/2020
• 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 Age: 38 YR
• Patient Weight: 64