MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; ANKLE CONTRACTURE BOOT

Model Number 4302B

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

The complaint call reported skin break down.There were no other details provided.No sample was returned.Sales representative has attemped to obtain more details from customer and has not been successful.Without any further information, the investigation team is unable to determine root cause.This is one of three complaints that came in at the same time for the same line of product from the same user facility.Complaint history between 01-01-2012 to 12-30-2016 was reviewed.There are no other skin breakdown complaints.No further information is available at this time.We will provide 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: no; detailed description of quality issue: skin break down with boot; how was the quality issue was identified: by actual use; how was the product being used: for positioning / pressure reduction; 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: other; person(s) affected by outcome(s) checked above: none; known pre-existing condition(s) of person(s) affected: skin breakdown; was the incident reported to the fda: no.

Manufacturer Narrative

The complaint call reported skin break down.There were no other details provided.No sample was returned.Sales representative has attempted to obtain more details from customer and has not been successful.Without any further information, the investigation team is unable to determine root cause.This is one of three complaints that came in at the same time for the same line of product from the same user facility.Complaint history between 01-01-2012 to 12-30-2016 was reviewed.There are no other skin breakdown complaints.No further information is available at this time.We will provide 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? no.Name of medical procedure: not applicable.Did the quality issue cause a delay in the medical procedure? not applicable.Detailed description of quality issue: skin break down with boot- how was the quality issue was identified? by actual use.How was the product being used? for positioning / pressure reduction.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: other.Person(s) affected by outcome(s) checked above: none.Known pre-existing condition(s) of person(s) affected: skin breakdown.Was the incident reported to the fda? no.

• Brand Name: DEROYAL
• Type of Device: ANKLE CONTRACTURE BOOT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; km7 autopista joaquin balaguer; pisano free zone, building 18; santiago, dominican republic ; DR
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; km7 autopista joaquin balaguer; pisano free zone, building 18; santiago, dominican republic ; DR
• Manufacturer Contact: elizabeth reed ; 200 debusk ln; powell 37849 ; 8653621256
• MDR Report Key: 6354170
• MDR Text Key: 68212138
• Report Number: 3006851902-2017-00005
• Device Sequence Number: 1
• Product Code: ITW
• 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
• Type of Report: Initial,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4302B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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