MAUDE Adverse Event Report: MEDLINE SENSICARE SURGICAL GLOVE, SIZE 7.5. ; SURGICAL GLOVES

Lot Number 606840451175

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

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

Event Date 06/22/2017

Event Type  malfunction  

Event Description

Sensicare surgical gloves size 7.5 has 2 dark spots on the outside of the left glove.Lot: 606840451175.Mfg: 06/2016, exp 05/2019.

• Brand Name: SENSICARE SURGICAL GLOVE, SIZE 7.5.
• Type of Device: SURGICAL GLOVES
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 6669495
• MDR Text Key: 78572935
• Report Number: MW5070637
• 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: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2019
• Device Lot Number: 606840451175
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1