MAUDE Adverse Event Report: SVS LLC PREMIERPRO; PATIENT EXAMINATION GLOVE, SPECIALTY

Model Number	5042
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Registered nurse (rn) went to grab chemo gloves out of box and glove ripped.

• Brand Name: PREMIERPRO
• Common Device Name: PATIENT EXAMINATION GLOVE, SPECIALTY
• Manufacturer (Section D): SVS LLC; 13034 ballantyne corporate pl; charlotte NC 28277
• MDR Report Key: 20683030
• Report Number: 20683030
• Device Sequence Number: 12571366
• Product Code: LZC
• UDI-Device Identifier: 00818566011985
• UDI-Public: (01)00818566011985
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2024
• Report Date (Section F): 10/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: 5042
• Device Catalogue Number: 5042
• Device Lot Number: CFM12-14
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/22/2024