MAUDE Adverse Event Report: DEROYAL GUATEMALA SLING & SWATHE, BLUE FOAM, ADJUSTABLE STRAPS; SLING, ARM

Catalog Number 9013-00

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Date 06/10/2014

Event Type  malfunction  

Event Description

Two days after surgery, the patient broke out in a severe rash with blisters everywhere the sling came in contact with their skin.

• Brand Name: SLING & SWATHE, BLUE FOAM, ADJUSTABLE STRAPS
• Type of Device: SLING, ARM
• Manufacturer (Section D): DEROYAL GUATEMALA; km 20.5 carretera a villa canales; villa canales ; GT
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653622333
• MDR Report Key: 4063010
• MDR Text Key: 4815381
• Report Number: 3005225477-2014-00016
• Device Sequence Number: 1
• Product Code: ILI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9013-00
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention