MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CORP. STERILE GRAVES VAGISPECULUM MED; SPECULUM, VAGINAL, METAL

Model Number GVSIOMST

Device Problem Nonstandard Device (1420)

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

Event Type  No Answer Provided  

Event Description

Recall# 2019080069.We do not have item in our inventory.

• Brand Name: STERILE GRAVES VAGISPECULUM MED
• Type of Device: SPECULUM, VAGINAL, METAL
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORP.; williamston MI
• MDR Report Key: 8912679
• MDR Text Key: 155549974
• Report Number: MW5089199
• Device Sequence Number: 1
• Product Code: HDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Device Model Number: GVSIOMST
• Device Lot Number: 2019041790/2019030490
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1