MAUDE Adverse Event Report: DEROYAL INDUSTIRES, INC. DEROYAL; ELBOW POSITIONER AND IMMOBILIZER WITH METAL STAYS

Model Number M7035-S

Device Problems Material Protrusion/Extrusion (2979); Naturally Worn (2988)

Patient Problem Abrasion (1689)

Event Date 07/01/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: the complaint sample was returned and inspected by the quality control investigator.The product was well worn.The material/body was damaged from wear and use.This included wearing down of the stay pocket resulting in the stay coming out.This product, m7035-s, is a pediatric elbow positioner/immobilizer is intended to be prescribed by a properly licensed practitioner to provide comfortable support while helping prevent patients from pulling i.V.Lines, nasogastric (ng) tubes and tracheostomy tubes.It is a type of restraint and it is contraindicated for a patient who is or may become highly aggressive or agitated.Based on the type of wear is seems to have been misused as a support brace by the end user or user facility.This would also contribute to the damage seen.In the complaint text it was also recorded that the therapist suggested that the original product was too short and allowed the patient to move her arms too much.A larger size product was requested as a replacement.It specifically asked for the larger size product # m7035-l.Correction: a larger size replacement was sent.Root cause analysis: it is concluded that excess wear, misuse and, improper fitting of product when it was issued resulted in material breakdown.Corrective action and/or systemic correction action taken: no action is required at this time since no manufacturing defect was found.Preventive action: no action is required at this time since no manufacturing defect was found.

Event Description

This complaint is on product number m7035-s.This is a pediatric elbow positioner/immobilizer is intended to be prescribed by a properly licensed practitioner to provide comfortable support while helping prevent patients from pulling i.V.Lines, nasogastric (ng) tubes and tracheostomy tubes.It is a type of restraint and it is contraindicated for a patient who is or may become highly aggressive or agitated.The customer reported that "metal stays have come out of material pockets and patient has cuts on her forearm and biceps." the patient had cuts from the stays were treated with topical ointment.

• Brand Name: DEROYAL
• Type of Device: ELBOW POSITIONER AND IMMOBILIZER WITH METAL STAYS
• Manufacturer (Section D): DEROYAL INDUSTIRES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; km 20.5 carretera a villa cana; villa canales, 01065 ; GT 01065
• Manufacturer Contact: marian vargas ; 200 debusk ln; powell, TN 37849 ; 8653621013
• MDR Report Key: 4936809
• MDR Text Key: 22958084
• Report Number: 3010452421-2015-00009
• 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
• Report Date: 07/01/2015,07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M7035-S
• Device Catalogue Number: 11342
• Device Lot Number: 39173312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/01/2015
• Event Location: Home
• Date Report to Manufacturer: 07/01/2015
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other