MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; SLING, ARM

Model Number 10105

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Irritation (2076)

Event Date 03/10/2017

Event Type  Injury  

Manufacturer Narrative

Regulatory specialist had a phone conversation with the end consumer on 3/21/17 related to call 40250 where the end consumer was broke out with a rash.The end consumer stated the rash appeared the next day after the initial use of the arm sling.She noticed the rash after her pain medication had worn off.She stated her arm was red and very itchy resulting in welts and scaling of the skin on her arm.Additional treatment was required, the end consumer followed up with her doctor and received a steroid shot.The end consumer stated she has a medical condition called lupus and has very sensitive skin resulting in a rash and or an allergic reaction each time she has had any surgery's in the past.The complaint sample was returned, the product is a light blue 10105 sling.The product shows sign of wear/use, there was no corrective action required at this time due to no manufacturing issues being found.Sensitivity to materials vary from person to person however, there is no latex in the product.The root cause was determined to be that the end user is highly sensitive to various materials due to a medical condition.Between, january 1, 2015 - march 30, 2017 there have been (b)(4) units sold and no complaints reported for the 10105 arm sling product related to a rash and or an allergic reaction.No further information is available at this time.We will provide a follow up report if additional information becomes available.

Event Description

*** quality issue details *** date of occurrence: (b)(6) 2017.When did quality issue occur? during use.Who was using or operating the product when the quality issue occurred? patient/end consumer.Was a medical procedure involved? yes.Name of medical procedure: shoulder surgery.Did the quality issue cause a delay in the medical procedure? no (please provide length of delay and any other details about the procedure in the detailed description field below).Detailed description of quality issue: she is broke out with a rash from her fingers to her elbow.Its where the sling touches her skin.How was the quality issue was identified? by actual use.How was the product being used? as described.Was it the initial use of the product? yes.Was the product modified from the original condition supplied by deroyal? no.Was the product connected to or used in conjunction with other devices or equipment? no.*** outcome details *** outcome(s) attributed to quality issue: none.Person(s) affected by outcome(s) checked above: patient.Known pre-existing condition(s) of person(s) affected: none specified.Was the incident reported to the fda? no.

• Brand Name: DEROYAL
• Type of Device: SLING, ARM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; km 20.5 carretera a; villa canales; villa canales, guatemala 01065 ; GT 01065
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; km 20.5 carretera a; villa canales; villa canales, guatemala 01065 ; GT 01065
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 6465292
• MDR Text Key: 72062762
• Report Number: 3010452421-2017-00002
• Device Sequence Number: 1
• Product Code: ILI
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10105
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2017
• 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): Other