MAUDE Adverse Event Report: O&M HALYARD, INC. POWDERFREE NITRILE TEXTURED GLOVE XS 50

Model Number	55090
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Contact Dermatitis (4546)
Type of Reportable Event	Serious Injury
Event or Problem Description
There was a dermatitis outbreak/severe reaction that occurred with the end-user requiring a doctor's care.There were no pictures or other information made available.Additional information was requested on october 18, 2024, october 21, 2024, october 23, 2024, and october 25, 2024; however, none has been received to date.
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.The product is contract manufactured by (b)(4) (fda registration number 3011189071).A scar was issued to the contract manufacturer on october 21, 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.

• Brand Name: POWDERFREE NITRILE TEXTURED GLOVE XS 50
• Common Device Name: POWDERFREE NITRILE TEXTURED GLOVE XS 50
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste. 320; alpharetta GA 30005
• Manufacturer (Section G): GP LUMUT; lot no. 15652, kawasan perindustrian; kampung acheh; sitiawan perak, malalysia 32000 ; MY 32000
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 20573301
• Report Number: 3014421917-2024-00018
• Device Sequence Number: 8555697
• Product Code: LZC
• UDI-Device Identifier: 30680651550904
• UDI-Public: 30680651550904
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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: 55090
• Device Catalogue Number: 991055090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/30/2024
• 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