MAUDE Adverse Event Report: MCKESSON MEDICAL SURGICAL INC. PREMIUM VAGINAL SPECULUM; PREMIUM VAGINAL SPECULA

Lot Number 222123

Device Problem Break (1069)

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

Event Date 04/02/2018

Event Type  malfunction  

Event Description

Speculums shatter very easily, one broke while using on patient and found packages with damage speculum which had to be discarded.

• Brand Name: PREMIUM VAGINAL SPECULUM
• Type of Device: PREMIUM VAGINAL SPECULA
• Manufacturer (Section D): MCKESSON MEDICAL SURGICAL INC. ; richmond VA 21233
• MDR Report Key: 7471951
• MDR Text Key: 106897976
• Report Number: MW5076837
• Device Sequence Number: 2
• Product Code: HIB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/10/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 222123
• Was Device Available for Evaluation?: No
• 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