MAUDE Adverse Event Report: SGP01 SINGAPORE GLV EXAM NITRILE FLEXAL PF SM; POLYMER PATIENT EXAMINATION GLOVE

Model Number	88TN02S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint was received and forwarded to the manufacturing site for investigation.At the time of investigation, no lot number was provided by customer.Without the lot number, we are unable to identify the manufacturer to review device history record for root cause investigation.Since the lot number was not provided, we are not able to review retained samples.The actual complaint sample was not returned for investigation.Based on the insufficient information received for investigation, the root cause was not identified due to no lot number being provided.No further action will be taken at this time unless a lot number or complaint sample is provided.We will continue to monitor trends and utilize the information as part of continuous improvement.
Event or Problem Description
Customer reported wearing gloves and after taking them off, nurse hands started burning/itching and turning splotchy red.Only one nurse had to see an allergist for medications.No patient demographic or information about type on medication were provided by the customer.

• Brand Name: GLV EXAM NITRILE FLEXAL PF SM
• Common Device Name: POLYMER PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): SGP01 SINGAPORE; 10 kallang avenue , #10-10/18; singapore 33951 0; SN 339510
• Manufacturer (Section G): SGP01 SINGAPORE; 10 kallang avenue , #10-10/18; singapore 33951 0; SN 339510
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 13625376
• Report Number: 1423537-2022-00727
• Device Sequence Number: 17408318
• Product Code: LZA
• UDI-Device Identifier: 20885380137119
• UDI-Public: 20885380137119
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 02/28/2022

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: 88TN02S
• Device Catalogue Number: 88TN02S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown