MAUDE Adverse Event Report: SEMPERMED USA, INC. STARMED ULTRA NITRILE EXAM GLOVE; MEDICAL GLOVES WITH CHEMOTHERAPY

Model Number SMTN254

Device Problem Defective Device (2588)

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

Event Date 03/03/2020

Event Type  malfunction  

Event Description

Glove removed from glove box with missing 5th digit finger.Manufacturer response for nonsterile gloves, starmed ultra nitrile (per site reporter).Equipment failure reported to customer service lead sempermed usa, inc.Quality event report emailed sempermed.Defective glove available to be returned to manufacturer.Awaiting response from manufacturer.

• Brand Name: STARMED ULTRA NITRILE EXAM GLOVE
• Type of Device: MEDICAL GLOVES WITH CHEMOTHERAPY
• Manufacturer (Section D): SEMPERMED USA, INC.; 13900 49th street north; clearwater FL 33762
• MDR Report Key: 9943168
• MDR Text Key: 187042516
• Report Number: 9943168
• Device Sequence Number: 1
• Product Code: OPJ
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMTN254
• Device Catalogue Number: SMTN254
• Device Lot Number: L020557 1712
• 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: 04/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33580 DA
• Patient Weight: 72