STERILE SG NITRILE GLOVES (SMALL)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-11 for STERILE SG NITRILE GLOVES (SMALL) manufactured by Halyard Health, Inc..

Event Text Entries

[138356655] Rn was using methaline blue dye during a procedure with gloves on throughout. During the procedure she felt "wetness" in her gloves. At conclusion of case, rn removed her gloves and noted she had blue staining in various spots on her hand. Rn inspected the gloves, and there were no holes noted. She reported she was very careful in removing gloves and did not accidently touch her hand with dye. She is concerned that if the dye was able to permeate through the glove, other matter may be able to as well. Gloves were removed from room.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	8407261
MDR Report Key	8407261
Date Received	2019-03-11
Date of Report	2019-02-27
Date of Event	2019-02-20
Report Date	2019-02-27
Date Reported to FDA	2019-02-27
Date Reported to Mfgr	2019-03-11
Date Added to Maude	2019-03-11
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Reporter Occupation	OTHER HEALTH CARE PROFESSIONAL
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	3
Previous Use Code	3
Event Type	3
Type of Report	3

Device Details

Brand Name	STERILE SG NITRILE GLOVES (SMALL)
Generic Name	POLYMER PATIENT EXAMINATION GLOVE
Product Code	LZA
Date Received	2019-03-11
Lot Number	SZ722628X_121
Device Availability	*
Device Eval'ed by Mfgr	*
Device Sequence No	1
Device Event Key	0
Manufacturer	HALYARD HEALTH, INC.
Manufacturer Address	5405 WINDWARD PARKWAY 3RD FLOOR WEST ALPHARETTA GA 30004 US 30004

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-03-11