MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD AQUASOFT POWDER FREE NITRILE EXAM GLOVE M; NITRILE EXAM GLOVES

Model Number	47636
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Anaphylactoid / Anaphylaxis (2218)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in this event is not available for evaluation.O&m halyard, inc.Is the specification developer and complaint handling establishment of the complaint product 47636, halyard aquasoft powder free nitrile exam glove.The product is contract manufactured by central medicare sdn bhd (fda registration number 3008253024).A scar was issued to the contract manufacturer on december 17, 2024.A follow-up report will be provided upon conclusion of investigation.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
There was one employee that showed signs of contact dermatitis after using the blue nitrile gloves.She developed swollen lips, tingling and had complaints of shortness of breath and throat tightening that was audible.
Additional Manufacturer Narrative
No complaint sample was received.Customer was unable to confirm complaint lot however they did indicate it was a size medium.Manufacturer found three potential lot numbers that had shipped to customer.The dhr for these was reviewed, no abnormalities were discovered.Five retained samples were tested for residual powder content, results were within specification.Ten samples from each potential complaint lot were sent to an external laboratory for residual accelerator testing, no residual accelerator was detected.Five office staff performed a wear test utilizing retained samples, no irritation or reaction was observed.There were no changes in raw materials used, compounding formulation or production processes.All materials were within specification for the three potential complaint lots.A root cause was not established.Complaint evaluation finds there is no positive trend or upward shifts for this complaint type for glove family in the past twelve months analyzed.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: HALYARD AQUASOFT POWDER FREE NITRILE EXAM GLOVE M
• Common Device Name: NITRILE EXAM GLOVES
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): CENTRAL MEDICARE SDN BHD; plot 2609-2620, batu 8; jalan changkat jong; teluk intan pera, my 36000 ; MY 36000
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 21023764
• Report Number: 3014421917-2024-00023
• Device Sequence Number: 20915284
• Product Code: LZC
• UDI-Device Identifier: 20680651476368
• UDI-Public: 20680651476368
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: 47636
• Device Catalogue Number: 47636
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown