MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. FULL BODY PATIENT SLING

Catalog Number MDS88200DSL

Device Problem Detachment Of Device Component (1104)

Patient Problem Hip Fracture (2349)

Event Date 05/03/2015

Event Type  Injury  

Event Description

It was reported that one of the loops detached from the sling and the end user fell.

Manufacturer Narrative

It was reported that on (b)(6) 2015 one of the loops on the sling detached while being used to transfer the end user.The end user fell.On (b)(6) 2015 she was at the hospital for unrelated issue and a left hip fracture was noted.There was no medical or surgical intervention initiated for the fracture.Due to her left sided paralysis and absence of symptoms, it is unk when the fracture actually occurred.The overall condition of the sling is not known.It was reported that the washing instructions stated on the label of the sling were not followed during the time it was used.This may have been a contributing factor to detached loop.The sample was not returned for eval.A root cause has not been confirmed.However, due to the reported injury and in an abundance of caution, this medwatch is being filed.

• Brand Name: FULL BODY PATIENT SLING
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4892488
• MDR Text Key: 6016735
• Report Number: 1417592-2015-00054
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS88200DSL
• Device Lot Number: A13070018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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: 39 YR
• Patient Weight: 82