MCKESON MEDI-PAK PF STRETCH VINYL EXAM GLOVES 14-814

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-12-17 for MCKESON MEDI-PAK PF STRETCH VINYL EXAM GLOVES 14-814 manufactured by Shijianzhung Hongray Group Co., Ltd..

Event Text Entries

[15019579] The individual's job entails washing and sterilizing instruments while wearing vinyl gloves. It was stated that on occasion, the individual's hands were wet once gloves were removed. No rips, holes or tears were noted or reported. The individual developed a rash and went to the dermatologist on (b)(6) 2013. On (b)(6) 2013, following a culture, the individual was informed they had contracted (b)(6). It is suspected by the user that the (b)(6) was contracted from water seeping through the gloves. An antibiotic and a cream (mupirocin) were prescribed. The user had a follow up appointment on (b)(6) 2013. According to the user on (b)(6) 2013, the rash still existed at the time of the follow up appointment. The dr extended the prescription of doxycycline for 30 more days and also prescribed yeast cream. Two more cultures were taken. One was negative. Results for the other one will not be received for 30 days. As of today ((b)(6) 2013), the rash is better. The lot number reported was obtained from the box of small gloves currently on the shelf at the customer's location. (b)(4) confirmed that this lot passed two rounds of pinhole testing; first by the manufacturer a final release and again by (b)(4) qa employees prior to shipment. Since the employee did not save the gloves used, there is no way to confirm that the gloves truly malfunctioned and/or contributed to the (b)(6) exposure. Also it was mentioned that the gloves were loose at the wrist ara and no other protection was donned by the employee. It is possible that the hands became wet due to water entry at the cuff site. Following a conversation with our clinical resource on (b)(6) 2013, gloves as well as gown cuffs over the wrist area, preventing skin exposure, are typically utilized to provide adequate protection while performing this type of task. Proper use of personal protective equipment (ppe) should be selected per the centers for disease control and prevention guidelines (guidelines for disinfection and sterilization in healthcare facilities, 2008, section c, 1c) to ensure that workers wear appropriate ppe to preclude exposure to infections agents or chemicals through the respiratory system, skin, or mucous membranes of the eyes, nose, or mouth. Ppe can include gloves, gowns, masks, and eye protection. The exact type of ppe depends on the infectious or chemical agent and the anticipated duration of exposure. The employer is responsible for making such equipment and training available. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1451040-2013-00002
MDR Report Key3541989
Report Source99
Date Received2013-12-17
Date of Report2013-11-15
Date of Event2013-11-01
Date Facility Aware2013-11-20
Report Date2013-11-15
Date Added to Maude2013-12-31
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMCKESON MEDI-PAK PF STRETCH VINYL EXAM GLOVES
Generic NameNONE
Product CodeLYZ
Date Received2013-12-17
Catalog Number14-814
Lot NumberCSHC09-11
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age3 MO
Device Sequence No1
Device Event Key0
ManufacturerSHIJIANZHUNG HONGRAY GROUP CO., LTD.
Manufacturer AddressNO. 135 XINHUA WEST ROAD SHIJIAZHUANG CITY, HEBEL 050081 CH 050081


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-12-17

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