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

Model Number 9011

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Urticaria (2278)

Event Date 01/01/1980

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 196398576
• Report Number: 1423537-2020-00443
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 10885380156489
• UDI-Public: 10885380156489
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9011
• Device Catalogue Number: 9011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 64