MAUDE Adverse Event Report: MECHANICSVILLE ECO PULL* LAVENDER* NITRILE POWDER-FREE EXAM GLOVES, M; LAVENDER NITRILE EXAM GLOVES

Model Number	44910
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Anaphylactoid / Anaphylaxis (2218)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the event report is not available for evaluation.A follow-up report will be provided upon the conclusion of the investigation.The reporter has indicated the affected employee has a latex allergy, however, there is no latex utilized in the manufacture of the glove.All information reasonably known as of 29 nov 2022 has been included in this medical device report.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.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 a o&m halyard, inc.Product is defective or has caused serious injury.Device not returned.
Event or Problem Description
An employee who used the lavender nitrile exam gloves experienced anaphylaxis.He/she has a latex allergy.
Additional Manufacturer Narrative
The product involved in the event report is not available for evaluation.The reporter has indicated the affected employee has a latex allergy, however, there is no latex utilized in the manufacture of the glove.Non-volatile residue and powder content test results from retained sample lot found all results to be within specification.No root cause was identified during investigation.We have logged this complaint into our database where we will monitor for any trends for this incident.All information reasonably known as of 09jan2022 has been included in this medical device report.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.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 a o&m halyard, inc.Product is defective or has caused serious injury.H3 other text : device not returned.

• Common Device Name: LAVENDER NITRILE EXAM GLOVES
• Manufacturer (Section D): MECHANICSVILLE; 9120 lockwood boulevard; mechanicsville VA 23116
• Manufacturer (Section G): SAFESKIN MEDICAL & SCIENTIFIC (THAILAND) LTD.; 200 moo8 kanchanavanich rd; tambol prik, amphur sadao; songkhla, thailand 90120 ; TH 90120
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 15885596
• Report Number: 9680760-2022-00001
• Device Sequence Number: 5250773
• Product Code: LZA
• UDI-Device Identifier: 20680651449102
• UDI-Public: 20680651449102
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202622
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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: 44910
• Device Catalogue Number: 104491001
• Device Lot Number: SV1267ZZZ_03AX
• 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: 11/02/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 01/09/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown