MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL INC. MCKESSON; PATIENT EXAMINATION GLOVE, SPECIALTY

Model Number 14-658C

Device Problems Material Discolored (1170); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 09/06/2022

Event Type  malfunction  

Event Description

Large gloves discolored, stuck together, and easily ripping.Reported to apsm.

• Brand Name: MCKESSON
• Type of Device: PATIENT EXAMINATION GLOVE, SPECIALTY
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC.; 9954 mayland drive; richmond VA 23233
• MDR Report Key: 15462256
• MDR Text Key: 300379695
• Report Number: 15462256
• Device Sequence Number: 1
• Product Code: LZC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 14-658C
• Device Lot Number: MBA05-06-L1F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1