MAUDE Adverse Event Report: BLUE COATED LEEP SPECULUM ; SPECULUM, VAGINAL, METAL

Device Problem Material Puncture/Hole (1504)

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

Event Date 08/21/2019

Event Type  malfunction  

Event Description

Blue coated leep speculum given to spd after the procedure.In spd it was noted that the speculum had a pinhole in it, with a bubble of red fluid (presumably blood) that would escape when pressing on the bubble.Fda safety report id# (b)(4).

• Brand Name: BLUE COATED LEEP SPECULUM
• Type of Device: SPECULUM, VAGINAL, METAL
• MDR Report Key: 9208125
• MDR Text Key: 163026308
• Report Number: MW5090473
• Device Sequence Number: 1
• Product Code: HDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/15/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1