MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; CAST PROTECTOR

Catalog Number WRX279024

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that while using the device on each leg, the leg casts became wet and had to be replaced.The operative sites were not affected.The sample was returned and evaluated.The openings of both protectors had stretch marks around it suggesting that both had been used.Moisture could be observed on the outside of the devices but not on the inside.It is not known if the cast protectors were appropriately applied prior to use to prevent water from entering.There was no indication of a manufacturing defect.A root cause has not been determined.Due to the need for the casts to be replaced, this medwatch is being filed.

Event Description

While using cast protectors bilaterally, both of the casts became wet and had to be replaced.

• Type of Device: CAST PROTECTOR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5590596
• MDR Text Key: 43081775
• Report Number: 1417592-2016-00042
• Device Sequence Number: 1
• Product Code: KIA
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: WRX279024
• Device Lot Number: 90115090037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Initial Date Manufacturer Received: 03/22/2016
• Initial Date FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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): Other
• Patient Age: 16 YR
• Patient Weight: 53