MAUDE Adverse Event Report: CARDINAL HEALTH 200 LLC PROTEXIS PI BLUE WITH NEU-THERA SURGICAL GLOVES WITH EMOLLIENT COATING.; SURGEON'S GLOVES

Model Number REF NUMBER 2D73EB75

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 04/18/2019

Event Type  Injury  

Event Description

A dead lizard found in packaging of sterile glove prior to patient's surgery.Pulled all gloves with matching lot numbers.Fda safety report id# (b)(4).

• Brand Name: PROTEXIS PI BLUE WITH NEU-THERA SURGICAL GLOVES WITH EMOLLIENT COATING.
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): CARDINAL HEALTH 200 LLC
• MDR Report Key: 8550619
• MDR Text Key: 143260081
• Report Number: MW5086162
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/22/2019

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: 04/01/2021
• Device Model Number: REF NUMBER 2D73EB75
• Device Lot Number: TSI8050363
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention