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)
Date of Event	11/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This emdr report was initially filed under mfr report number - 3014421917-2024-00018 and should have been filed under mfr number the correct mfr report number for safeskin medical & scientific (thailand), ltd.G1 all manufacturer's section correction to: safeskin medical & scientific (thailand), ltd.200 moo 8 kanchanavanich road tambol prik sadao songkhla, th 90120.The product involved in this event is not available for evaluation.Product device history record was reviewed, in process and final release inspections were found to be conforming.The retained samples were utilized to perform wear testing where five operators wore the gloves for an extended period of time.The test results did not show any irritation or itching issue on testing operator hands.A root cause was not identified.There are no corrective/preventive actions taken at this time.The reported complaint will be trended and monitored closely as part of continuous improvement needs.At this time there has only been one similar complaint in 2024, this equates to 0.003 complaints per million.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint comp(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 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
This emdr report was initially filed under mfr report number - 3014421917-2024-00018, this report should have been filed under mfr number.The correct mfr report number for safeskin medical & scientific (thailand), ltd.G1 correction all manufacturer's section to: safeskin medical & scientific (thailand), ltd.200 moo 8 kanchanavanich road tambol prik sadao songkhla, th 90120 the reporter initially reported one severe dermatitis reaction requiring medical care.They did not specify which product or lot resulted in this incident, but did provide several lots without product identification.A complaint was opened for each of these to initiate investigation while waiting on the reporter to respond with additional details.The related report numbers in h10 represent those other potential products.The customer has since provided clarification that the dermatitis did not require any medical intervention or treatment.For this potential product, the manufacturing site reviewed the device history record.All in-process and final release criteria were met with no contributing factors identified.The retained lot samples were evaluated and met all visual inspection criteria.A wear test was performed involving 5 different operators wearing the gloves for an extended period of time.No dermatitis or irritation was observed during or after test was performed.There is no trend for this issue for the glove product family.A root cause was not identified.Complaints are monitored on an ongoing basis via statistical evaluation, should a trend or further complaints be received for issue, additional investigation and corrective action evaluation will ensue.
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 at time of complaint receipt.

• 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): SAFESKIN MEDICAL & SCIENTIFIC (THAILAND), LTD.; 200 moo 8 kanchanavanich road; tambol prik; sadao songkhla, th 90120 ; TH 90120
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 20940089
• Report Number: 9614175-2024-00006
• Device Sequence Number: 4566843
• Product Code: LZC
• UDI-Device Identifier: 30680651550904
• UDI-Public: 30680651550904
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: 55090
• Device Catalogue Number: 991055090
• Device Lot Number: SM2352ZZZ_31BX
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 01/08/2025
• 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