MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BENCH,TRANSFER,PADDED

Catalog Number G98338MF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Neck Pain (2433)

Event Date 10/16/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the end-user experienced a fall from the padded transfer bench while she was taking a shower.Reportedly, the back of the padded transfer bench broke off and the end-user fell into her bathtub.Paramedics were called and she was taken to the local hospital.An x-ray was performed with no acute fractures reported.No other diagnostic testing reported.Reportedly, the end-user was diagnosed with "whip-lash" to her neck, placed into a hard cervical collar, and was admitted to the hospital for observation.The sample was reportedly discarded and was not returned to the manufacturer for evaluation.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the end-user experienced a fall and was admitted to the hospital for observation.

• Type of Device: BENCH,TRANSFER,PADDED
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 7457710
• MDR Text Key: 106405429
• Report Number: 1417592-2018-00033
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: G98338MF
• Device Lot Number: 88517050031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 81