MAUDE Adverse Event Report: DISPOSABLE VAGINAL SPECULUM

Model Number DX010M

Device Problems Break (1069); Crack (1135)

Patient Problem Corneal Abrasion (1789)

Event Date 01/12/2017

Event Type  malfunction  

Event Description

Md was completing a pelvic exam.As md attempted to remove the speculum from the patient, the speculum cracked, a piece of plastic broke off, and the piece flew into the md's right eye.Md was treated for a corneal abrasion.Mfr name: (b)(4).

• Brand Name: DISPOSABLE VAGINAL SPECULUM
• Type of Device: DISPOSABLE VAGINAL SPECULUM
• MDR Report Key: 6431792
• MDR Text Key: 70909814
• Report Number: MW5068650
• Device Sequence Number: 1
• Product Code: HIB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DX010M
• Device Catalogue Number: 1126155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: Yes
• 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