MAUDE Adverse Event Report: O&M HALYARD, INC. K-C STERLING TEXTURED GLOVE L 100; STERLING NITRILE EXAM GLOVES

Model Number	53140
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Local Reaction (2035)
Type of Reportable Event	Serious Injury
Event or Problem Description
An employee reported that while wearing gloves they smelled a chemical and started coughing immediately.The employee had difficulty breathing.There were odors also reported from garbage where gloves were disposed of previously.These odors triggered more coughing and difficulty breathing from the employee.The reporter indicated there was medical intervention taken, but they were unwilling or unable to provide further details with us when asked.
Additional Manufacturer Narrative
The product involved in the event was not available for return.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 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 a o&m halyard, inc.Product is defective or has caused serious injury.H3 other text : device not returned.
Additional Manufacturer Narrative
Nine dispenser boxes were returned by complainant for evaluation.There was no odor noted on the gloves themselves; however, odor was detected on the dispenser boxes (packaging).Retained samples from the same lot were evaluated.There was no odor noted on the gloves or dispenser boxes (packaging).A cpm (complaints per million) trending evaluation was performed, the cpm was within control limits and there were no negative trends for this issue noted.A device history record evaluation was performed and no contributing issues were noted, the product documentation concluded product was manufactured according to approved specifications and passed all inspections.No root cause was identified.The complaint incident will be trended and monitored for future continual improvement needs.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, 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: K-C STERLING TEXTURED GLOVE L 100
• Common Device Name: STERLING NITRILE EXAM GLOVES
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): SAFESKIN MEDICAL & SCIENTIFIC (THAILAND) LTD.; 200 moo 8 kanchanavanich road; tambol prik, amphur sadao; songkhla, thailand 90120 ; TH 90120
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 18307319
• Report Number: 9614175-2023-00001
• Device Sequence Number: 6615573
• Product Code: LZC
• UDI-Device Identifier: 30680651531408
• UDI-Public: 30680651531408
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K081089
• 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): 01/11/2024

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: Lay User/Patient
• Device Model Number: 53140
• Device Catalogue Number: 991053140
• Device Lot Number: SM3028ZZZ_29C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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