MAUDE Adverse Event Report: SVS LLC PREMIERPRO VAGINAL SPECULUM, LIGHTED, STERILE, SIZE LARGE; SPECULUM, VAGINAL, NONMETAL

Model Number 5342

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2023

Event Type  malfunction  

Event Description

Lights on our large lighted speculums are not bright enough to use.

• Brand Name: PREMIERPRO VAGINAL SPECULUM, LIGHTED, STERILE, SIZE LARGE
• Type of Device: SPECULUM, VAGINAL, NONMETAL
• Manufacturer (Section D): SVS LLC; 13034 ballantyne corporate pl.; charlotte NC 28277
• MDR Report Key: 16521394
• MDR Text Key: 311055624
• Report Number: 16521394
• Device Sequence Number: 1
• Product Code: HIB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5342
• Device Catalogue Number: 5342
• Device Lot Number: CBEI 08-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1