MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL S.L.R SHOULDER P.A.D II, ABDUCTION DEVICE M; SLING ARM

Catalog Number 11630006

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

Patient Problem Rash (2033)

Event Date 07/09/2014

Event Type  malfunction  

Event Description

The patient's skin broke out in a rash after using the product.Every part of the skin that the sling has touched broke out in a rash.

Manufacturer Narrative

Investigation findings: the complaint sample was returned, the product shows sign of wear/use (has some debris/hair on it) no manufacturing issue was found.I have attached the bom for the (b)(4) along with the component evaluation form, msds and technical data sheet for the sling raw material.Correction: replacement sent of the shoulder pad iii.Root cause analysis: unable to determine, several factors including heat, medication and ones own sensitivity to certain chemicals/materials can cause an allergic reaction.Corrective action and/or systemic correction action taken: no action required at this time, no manufacturing issue found, i do not recall any like complaints for this item.No further information available at this time.Will provide follow ups if additional information becomes available.

• Brand Name: SHOULDER P.A.D II, ABDUCTION DEVICE M
• Type of Device: SLING ARM
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL S.L.R; km 7 autopista joaquin balaguer; pisano free zone, building 18; santiago ; DO
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653622333
• MDR Report Key: 4055504
• MDR Text Key: 4734076
• Report Number: 3006851902-2014-00001
• 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: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 11630006
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/25/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/16/2014
• Event Location: Home
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention