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

Catalog Number WRX279024

Device Problem Moisture or Humidity Problem (2986)

Patient Problem Skin Irritation (2076)

Event Date 09/24/2014

Event Type  Injury  

Event Description

While using the cast protector, the cast became wet and had to be replaced.

Manufacturer Narrative

It was reported that while using the device, the leg cast became wet and had to be replaced.Some skin irritation of the heel was noted when the original cast was removed.The end user's mother tested the cast protector for leaks following the incident and none were found.The sample was not returned for evaluation.We have no lot number.A sample was pulled from stock and evaluated.No abnormalities were identified.It is not known if the top opening of the cast protector was appropriately secured prior to use to prevent water from entering.There is no indication that the incident was caused by a manufacturing defect.Without the actual sample a root cause has not been confirmed.Due to the need for the cast to be replaced, this medwatch is being filed.

• Brand Name: CAST PROTECTOR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4196863
• MDR Text Key: 4963009
• Report Number: 1417592-2014-00095
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 10/14/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2014
• Initial Date FDA Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 14 YR