MAUDE Adverse Event Report: TRADEX INTERNATIONAL, INC. / CARDINAL HEALTH 200, LLC AMBITEX V200 SERIES VINYL EXAM GLOVES; VINYL PATIENT EXAMINATION GLOVE

Model Number VXL200

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Pt states that after opening the box of ambitex v200 series vinyl exam gloves and taking one glove out, he noticed at a contamination inside.Pt reports that at the end of the exam glove towards the rolled up fabric at the wrist area, there was a big black clump of foreign material rolled into the glove.Pt states this contamination seems to be from production.Pt also notes that no he only noticed contamination on singular glove but did not examine the rest from the box.

• Brand Name: AMBITEX V200 SERIES VINYL EXAM GLOVES
• Type of Device: VINYL PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): TRADEX INTERNATIONAL, INC. / CARDINAL HEALTH 200, LLC
• MDR Report Key: 11738074
• MDR Text Key: 248080485
• Report Number: MW5101050
• Device Sequence Number: 1
• Product Code: LYZ
• 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: 04/27/2021

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: 01/11/2021
• Device Model Number: VXL200
• Device Catalogue Number: VXL200
• Device Lot Number: T412200601
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1