MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. 3 POSITION RECLINER

Catalog Number FURN10100BLT

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

Patient Problem Bone Fracture(s) (1870)

Event Date 03/11/2015

Event Type  Injury  

Event Description

The end user fell while she was getting up from the recliner and fractured her coccyx.

Manufacturer Narrative

It was reported that the end user pushed up to stand from a seated position and the brakes on the casters did not hold.She fell, fracturing her coccyx.It is unk if the casters were securely engaged in the locked position at the time of the incident.The fracture healed by itself.A sample has not been returned for evaluation.The manual states that routine maintenance and inspection of the casters should be performed.The contact at the facility was not aware that this had been done since they began using it in 2011.We have not confirmed the presence of a manufacturing defect or failure.A root cause has not been determined, however the lack of maintenance and inspection of the casters cannot be ruled out as a cause or contributing factor.

• Brand Name: 3 POSITION RECLINER
• Type of Device: NI
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley, ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4808819
• MDR Text Key: 17580880
• Report Number: 1417592-2015-00044
• Device Sequence Number: 1
• Product Code: KMN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FURN10100BLT
• Device Lot Number: A110744614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 94