MAUDE Adverse Event Report: MEDLINE SENSICARE GLOVES

Catalog Number MSG1070

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 05/22/2017

Event Type  malfunction  

Event Description

Technician discovered 2 pairs of contaminated medline sensicare size 7 gloves (ref: (b)(4), lot # 612893046370, exp 11/2019) which have brown spotting/specking on them.

• Brand Name: SENSICARE GLOVES
• Type of Device: SENSICARE GLOVES
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 6587331
• MDR Text Key: 75964840
• Report Number: MW5069999
• 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: 05/22/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: MSG1070
• Device Lot Number: 612893046370
• 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