MAUDE Adverse Event Report: 2182356 BREWER ACCESS EXAM TABLE; CHAIR, EXAMINATION AND TREATMENT

Model Number 5000-04

Device Problem No Fail-Safe Mechanism (2990)

Patient Problem Skin Tears (2516)

Event Date 07/30/2018

Event Type  Injury  

Event Description

According to the reporting person, a "rather large" patient placed his left hand on and somewhat under the upholstered top.When he sat on the table, his left hand middle finger was cut by something sharp, and his finger/nail fell on floor.The plastic surgical repair was the next morning using a skin graft of pig's skin.When i asked her to clarify "rather large", she stated (b)(6) lb.She stated that "apparently the bumpers fall off easily.After the incident, when we looked at the 37 tables in the clinic, we found 18 tables that were missing one or both of the bumpers." she had their service company come in to replace the missing bumpers.The table was most recently inspected in january by their service company.Picture sent by the reporting person showed no bumper or screw on one side.The reporting person stated that there was not a specific sharp edge on the table.(refer to mw5081405).

• Brand Name: BREWER ACCESS EXAM TABLE
• Type of Device: CHAIR, EXAMINATION AND TREATMENT
• Manufacturer (Section D): 2182356; n88 w13901 main street; suite 100; menomonee falls WI 53051
• Manufacturer (Section G): THE BREWER COMPANY LLC; n88 w13901 main street; suite 100; menomonee falls WI 53051
• Manufacturer Contact: emily vande hei ; n88 w13901 main street; suite 100; menomonee falls, WI 53051 ; 2622937164
• MDR Report Key: 8430505
• MDR Text Key: 139163390
• Report Number: 2182536-2018-00001
• Device Sequence Number: 1
• Product Code: FRK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5000-04
• Device Catalogue Number: 5000-04
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 16 YR
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 64 YR
• Patient Weight: 113