MAUDE Adverse Event Report: MEDLINE SENSICARE

Model Number MSG1070

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2017

Event Type  malfunction  

Event Description

Upon opening package of medline sensicare size 7 sterile gloves (ref# (b)(4), lot # 612887157170, exp.Nov.2019) technician noticed brown spotting on the gloves.

• Brand Name: SENSICARE
• Type of Device: SENSICARE
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 6673053
• MDR Text Key: 78712728
• Report Number: MW5070667
• Device Sequence Number: 1
• Product Code: KGO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Model Number: MSG1070
• Device Lot Number: 612887157170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1