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

Model Number	88TN04L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anaphylactic Shock (1703)
Date of Event	04/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported a 45 year old female staff member was prepping the patient for a vein ablation.They put on the same nitrile gloves they've been using for years and within a minute of having the gloves on, their palms began to itch.They removed the gloves and washed their hands, then shortly afterwards their hands started turning red and swelling.Around 3 minutes later, their chest started to get a rash.5 minutes in, their tongue and throat began to swell to the point that they were unable to swallow.The staff member was taken to the emergency room at piedmont fayette, where the emergency department administered two rounds of epi, and they received benadryl via iv fluids.They were monitored in the emergency department for 4-5 hours and was subsequently discharged and was sent home with prednisone 20mg to be taken for 1 week.The staff member advised they are 95% sure that the product that caused the adverse reaction was flexal glove nitrile from cardinal health.They additionally stated that their facility is latex free and there are no latex products on site.
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.
Additional Manufacturer Narrative
A supplemental report is being filed following the submission of the initial mdr report since the investigation is available.A sample was received for investigation.Based on the supplier¿s investigation, donning testing for 4 hours on the samples received and on retained samples, showed there was no skin allergy problem.The device history record (dhr) review for reported lot number showed the product was inspected and released in compliance with all requirements.Therefore, the root cause could not be determined.Cardinal health will continue to monitor and trend all similar reported product related issues.

• Brand Name: GLV EXAM NITRILE FLEXAL PF LG
• 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: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 19554534
• Report Number: 1423537-2024-00042
• Device Sequence Number: 20515746
• Product Code: LZA
• UDI-Device Identifier: 20885380137133
• UDI-Public: 20885380137133
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 88TN04L
• Device Catalogue Number: 88TN04L
• Device Lot Number: CN05AA3H038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2024
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 86 KG