MAUDE Adverse Event Report: MEDLINE SENSICARE GLOVES

Catalog Number MSG1070

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

Patient Problem No Information (3190)

Event Date 04/18/2017

Event Type  malfunction  

Event Description

Tech opened a pair of midline sensicare sterile gloves, size 7 (lot# 607859831970, ref/item# msg1070) to discover some brownish spotting on the gloves.Medline contacted, quality complaint #(b)(4) assigned.Affected gloves to be returned to medline for analysis.Pull that lot number out of circulation.

• Brand Name: SENSICARE GLOVES
• Type of Device: SENSICARE GLOVES
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 6529586
• MDR Text Key: 74075765
• Report Number: MW5069397
• 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: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: MSG1070
• Device Lot Number: 607859831970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2017
• 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