MAUDE Adverse Event Report: SGP01 SINGAPORE GOWN STER XLRG W/TOWEL; GOWN, SURGICAL

Model Number	9545
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Skin Irritation (2076)
Date of Event	01/01/1980
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Customer reported a nurse developed redness and hives on her arms while wearing aami level 3 non-reinforeced surgical gown xl 9545 requiring an intramuscular steroid injection and oral benadryl.She has history of allergy to formaldehyde.The event date is unknown by the customer.Report filed for serious injury.
Additional Manufacturer Narrative
Supplemental report being filed since the results of investigation are available.Based on supplier investigation, device history record review did not indicate any exception that could lead to the reported incident.There is 1 occurrence reported in the past 12 months.No sample was returned for investigation, only photos were provided.Observation of the photos provided shows the skin irritating area is found on the back of hand, but the back of hand will not make contact with the gown.The wrist area is a no seal line and does not come in contact with the gown.There was no change in raw material or production process and packing process.Supplier checked both in-process and finished goods inspection records, which showed that there is no abnormality found during the whole production process.There is no abnormality found in the test record of environment control.From the investigation, the root cause could not be determined.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.

• Brand Name: GOWN STER XLRG W/TOWEL
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): SGP01 SINGAPORE; 10 kallang avenue , #10-10/18; singapore 33951 0; SN 339510
• MDR Report Key: 10549976
• Report Number: 1423537-2020-00524
• Device Sequence Number: 3216286
• Product Code: FYA
• UDI-Device Identifier: 10192253010565
• UDI-Public: 10192253010565
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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: 9545
• Device Catalogue Number: 9545
• Device Lot Number: 19DCQ002
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/18/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 09/25/2020
• 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: 54 YR
• Patient Weight: 84