DEROYAL 4302C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-23 for DEROYAL 4302C manufactured by Deroyal Industries, Inc..

Event Text Entries

[68167386] 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.
Patient Sequence No: 1, Text Type: N, H10


[68167387] *** 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.
Patient Sequence No: 1, Text Type: D, B5


[71515918] 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.
Patient Sequence No: 1, Text Type: N, H10


[71515919] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006851902-2017-00003
MDR Report Key6354172
Report SourceUSER FACILITY
Date Received2017-02-23
Date of Report2017-01-26
Date of Event2017-01-26
Date Mfgr Received2017-01-26
Date Added to Maude2017-02-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. ELIZABETH REED
Manufacturer Street200 DEBUSK LN
Manufacturer CityPOWELL 37849
Manufacturer CountryUS
Manufacturer Postal37849
Manufacturer Phone8653621256
Manufacturer G1DEROYAL INDUSTRIES, INC.
Manufacturer StreetKM7 AUTOPISTA JOAQUIN BALAGUER PISANO FREE ZONE, BUILDING 18
Manufacturer CitySANTIAGO, DOMINICAN REPUBLIC
Manufacturer CountryDR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEROYAL
Generic NameANKLE CONTRACTURE BOOT
Product CodeITW
Date Received2017-02-23
Model Number4302C
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEROYAL INDUSTRIES, INC.
Manufacturer AddressKM7 AUTOPISTA JOAQUIN BALAGUER PISANO FREE ZONE, BUILDING 18 SANTIAGO, DOMINICAN REPUBLIC DR


Patients

Patient NumberTreatmentOutcomeDate
10 2017-02-23

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