MAUDE Adverse Event Report: MEDLINE INDUSTRIES SENSICARE ICE; VINYL PATIENT EXAMINATION GLOVE

Model Number MDS6801

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2017

Event Type  malfunction  

Event Description

While donning nitrile exam gloves, the clinicians noticed some type of material in the gloves.Upon inspection of the glove, the clinician removed a foreign object from the glove.The glove and object were retrieved and sent to biomedical, along with the original glove container to be sent to the manufacturer for analysis and reporting.The clinician ordered a new box of exam gloves.No apparent patient harm from this event.Manufacturer response for gloves, exam, nitrile, sensicare ice (per site reporter).Awaiting follow-up from manufacturer.

• Brand Name: SENSICARE ICE
• Type of Device: VINYL PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): MEDLINE INDUSTRIES; lara simmons; one medline pl.; mundelein IL 60060
• MDR Report Key: 7107654
• MDR Text Key: 94502656
• Report Number: 7107654
• Device Sequence Number: 1
• Product Code: LYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MDS6801
• Device Catalogue Number: MDS6801
• Device Lot Number: AN709540946
• Other Device ID Number: SENSICARE ICE BLUE NITRILE EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other