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

Catalog Number CUR200ALL

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Code Available (3191)

Event Date 07/01/2014

Event Type  Injury  

Event Description

The dressing became wet while showering and the apligraf was replaced.

Manufacturer Narrative

Apligraf had been applied to a left foot wound one month prior to the incident.Last month while showering, the end user stated he felt water inside the protector.His dressing became wet and the apligraf on his foot had to be reapplied.The protector was not returned to use for eval.It is not known if it was applied correctly or if there was any damage to the protector prior to or during use.A root cause has not been determined.We have not confirmed that a defect existed but in an abundance of caution this medwatch is being filed.

• Brand Name: CAST AND BANDAGE PROTECTOR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4006329
• MDR Text Key: 4958722
• Report Number: 1417592-2014-00076
• 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: 08/06/2014

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: CUR200ALL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 08/06/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR