SYNTHETIC POLYISOPRENE, SENSICARE SURGICAL GLOVES WITH ALOE VERA MSG1080

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-14 for SYNTHETIC POLYISOPRENE, SENSICARE SURGICAL GLOVES WITH ALOE VERA MSG1080 manufactured by Medline Industries, Inc..

Event Text Entries

[139168507] Medline size 8, synthetic polyisoprene, sensicare surgical gloves with aloe vera, discovered to have a pin hole in the area of the anterior right index finger upon donning. Sterile packaging was secured and noted to be intact.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5084942
• MDR Report Key: 8424995
• Date Received: 2019-03-14
• Date of Report: 2019-03-14
• Date of Event: 2019-03-13
• Date Added to Maude: 2019-03-15
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• 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: 0

Device Sequence Number: 0

• Brand Name: SYNTHETIC POLYISOPRENE, SENSICARE SURGICAL GLOVES WITH ALOE VERA
• Generic Name: SURGICAL GLOVES / SURGEON'S
• Product Code: KGO
• Date Received: 2019-03-14
• Model Number: MSG1080
• Catalog Number: MSG1080
• Lot Number: 8126010280-2
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: MEDLINE INDUSTRIES, INC.

Device Sequence Number: 1

• Brand Name: SYNTHETIC POLYISOPRENE, SENSICARE SURGICAL GLOVES WITH ALOE VERA
• Generic Name: SURGICAL GLOVES / SURGEON'S
• Product Code: KGO
• Date Received: 2019-03-14
• Model Number: MSG1080
• Catalog Number: MSG1080
• Lot Number: 8126010280-2
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDLINES INDUSTRIES, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-03-14