MAUDE Adverse Event Report: SROUFE HEALTHCARE PRODUCTS DEROYAL; TENNIS ELBOW STRAP

Model Number 12840000

Device Problems Gel Leak (1267); Fungus in Device Environment (2316); Device Packaging Compromised (2916)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured by an outside vendor.Our supplier for this item is (b)(4) it is sold under two different part numbers; 12840000 and 200a10.Investigation findings: quality control has pulled all of item 12840000 and 200a10 from the shelves at our distribution facility.Several of the units were covered with what appears to be mold.Other product items appeared to have moisture inside the package.This issue was also found in a new shipment that had not been received (not put into the computer system) or stocked on the shelf.As a result, we pulled the entire inventory and placed the product in quarantine.The 5 product samples for this quality issue were received from the customer and added to the quarantined items.The vendor was contacted and a scar (supplier corrective action request form) was sent for completion, along with photos of the issues found.Quality control did make an inquiry to the vendor if they required a sample for review, but was informed "if you haven't sent the samples already please don't.We pulled our inventory and see what the issue is".Per vendor instructions, our inventory of this product was pulled.The vendor's scar (supplier corrective action request) was received 11/07/2017.Root cause: sealed packaging of the components retained environmental moisture.Lack of climate control in warehouse area.Sealed packaging of the finished goods retained environmental moisture.During container shipment, humidity and heat led to mold formation.Corrective action: raw materials for the affected item to be stored in vented packages in climate and humidity controlled area.Desiccant/vents added to finished goods packaging.Finished goods to be stored in a temperature/humidity controlled environment prior to shipment.Increased inspection upon us arrival.Verification: assess packaging on other items produced for deroyal items to determine if other changes are needed.Verification: periodic inspection of stored raw materials by personnel.A 100% inspection of raw materials before production.Initial 100% inspection of finished goods received at us distribution center upon receipt for next 3 orders.Increased sampling on future orders.No further information is available at this time.We will provide a follow up report if additional information becomes available.

Event Description

It was reported "the gel patch is leaking on 5 of the elbow straps, we had 1 that was not damp that i dispensed to the patient.The quality issue occurred before use.It was confirmed that a medical procedure was not involved.The quality issue was identified through visual inspection and was found damaged upon arrival.The product was not modified from the original condition supplied by deroyal and was not used in conjunction with other devices or equipment.It was confirmed that the 5 product samples had a leaking issue, but mold was not initially identified by the end user.

• Brand Name: DEROYAL
• Type of Device: TENNIS ELBOW STRAP
• Manufacturer (Section D): SROUFE HEALTHCARE PRODUCTS; 961 seville road; wadsworth OH 44281
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 hwy 33 south; new tazewell TN 37825
• Manufacturer Contact: elizabeth reed ; 200 debusk lane; powell, TN 37849 ; 8653621256
• MDR Report Key: 6112358
• MDR Text Key: 60316986
• Report Number: 1060680-2016-00037
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 12840000
• Device Lot Number: 47001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other