MAUDE Adverse Event Report: MEDLINE MEDLINE SPECULUM

Lot Number 17QB5793

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/06/2017

Event Type  Injury  

Event Description

Pt was having a vaginal exam using speculum.Top piece of speculum broke at base.Top piece removed from vaginal canal without injury or incident.Each speculum comes in individual package.Lot no: 17qb5793.Reorder #(b)(4), exp 11/30/2020, mfr - medline.

• Brand Name: MEDLINE SPECULUM
• Type of Device: MEDLINE SPECULUM
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 6940442
• MDR Text Key: 89254002
• Report Number: MW5072700
• Device Sequence Number: 1
• Product Code: HIB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Lot Number: 17QB5793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR