MAUDE Adverse Event Report: SVS LLC PREMIERPRO SURGEONS GLOVE; SURGEON'S GLOVES

Lot Number CZJ 04-02

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 07/10/2020

Event Type  malfunction  

Event Description

Nurse pulled a glove from the box of gloves in the patient room and the glove had black debris on it.When she went for additional gloves in the same box a clump of black debris was found.Many of the gloves in the box have black debris on them.

• Brand Name: PREMIERPRO SURGEONS GLOVE
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): SVS LLC; 14120 ballantyne corporate pl ste 425; charlotte NC 28277
• MDR Report Key: 10395253
• MDR Text Key: 202524216
• Report Number: 10395253
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2020,07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: CZJ 04-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1