FDA.reportPublic FDA data

MAUDE MDR 5532645

MDR report key
5532645
Report number
3010452421-2016-00005
Event key
0
Event type
3
Date of event
2016-02-29
Date received
2016-03-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
DR. MARIAN VARGAS
Address
200 DEBUSK LN POWELL 37849 US
Phone
865-865-8653
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEROYAL PRUVENTORHEEL PROTECTOR, PRUVENTOR, LONG W/ANTI-ROTATION WEDGEDEROYAL INDUSTRIES, INC.FMPM70-100LR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-03-2901. O

Event Narratives#

N

Patient 1

SEVEN COMPLAINTS (DEROYAL REF. NO. (B)(4)) WERE FILED AT THE SAME TIME FROM THE SAME USER FACILITY (V A MED CTR MINNEAPOLIS) FOR PRODUCTS WITH THE SAME PART NUMBER (M70-100L - HEEL PROTECTOR, PRUVENTOR, LONG W/ANTI-ROTATION WEDGE) EACH REPORTING THE SAME ADVERSE EVENT. A MEDICAL DEVICE REPORT (MDR) IS BEING FILED FOR EACH COMPLAINT. THE LIST OF COMPLAINTS AND CORRESPONDING MDR IS LISTED BELOW. (B)(4) MDR NO. 3010452421-2016-00001, (B)(4) MDR NO. 3010452421-2016-00002, (B)(4) MDR NO. 3010452421-2016-00003, (B)(4) MDR NO. 3010452421-2016-00004, (B)(4) MDR NO. 3010452421-2016-00005, (B)(4) MDR NO. 3010452421-2016-00006, (B)(4) MDR NO. 3010452421-2016-00007. INVESTIGATION FINDINGS: THE INVESTIGATION TEAM FOLLOWED UP THE INITIAL REPORT WITH ADDITIONAL QUESTIONS. THE QUESTIONS ARE COPIED BELOW. IN ADDITION, NO COMPLAINT SAMPLES HAVE BEEN RECEIVED BY DEROYAL FOR ANALYSIS. RESPONSES ARE LISTED BELOW. WE ARE STILL WAITING FOR ADDITIONAL INFORMATION. WHERE WAS LOCATION OF THE PRESSURE ULCERS? USER FACILITY STATED THAT THE PRESSURE ULCER WAS ON THE BACK OF THE CALF. WE WOULD LIKE TO VERIFY WHEN DID EACH OF THESE EVENTS OCCUR? NO RESPONSE ON THIS QUESTION FROM USER FACILITY. WHAT TYPE OF PATIENTS DID THIS HAPPEN WITH? EX. ELDERLY, YOUNG, MIDDLE AGE, DIABETIC USER FACILITY RESPONDED THAT ALL PATIENTS WITH THE PRESSURE ULCERS HAD SPINAL CORD INJURIES. THERE WAS NO INFORMATION GIVEN AS TO ANY OTHER OR ADDITIONAL PATIENT CONDITION. ROOT CAUSE: THE INVESTIGATION TEAM IS UNABLE TO DETERMINE A ROOT CAUSE. THERE ARE SEVERAL FACTORS THAT INCREASE THE FORMATION OF PRESSURE ULCERS. IN THIS CASE, WE DO NOT HAVE ENOUGH INFORMATION TO UNDERSTAND WHAT CAUSED THE HOSPITAL ACQUIRED PRESSURE ULCER. THE CUSTOMER/USER FACILITY HAS NOT RESPONDED TO ALL OF OUR INQUIRIES. ALSO NO SAMPLE WERE SENT BACK FOR ANALYSIS. THE INTENDED USE FOR THIS PRODUCT IS TO "HELP PREVENT HEEL DECUBITUS ULCER." IT IS IMPORTANT THE CORRESPONDING HEALTH PROFESSIONAL TO "READ ALL INSTRUCTIONS, WARNINGS, AND PRECAUTIONS BEFORE USE. CORRECT APPLICATION IS ESSENTIAL FOR PROPER FUNCTIONING OF THE PRODUCT." THIS IS STATED IN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU). THE IFU ALSO INSTRUCTS TO THE CORRESPONDING HEALTH CARE PROFESSIONAL TO "PERFORM PERIODIC SKIN ASSESSMENT." CORRECTIONS: NO CORRECTIONS WERE NECESSARY. CORRECTIVE ACTION: NO ROOT CAUSE WAS FOUND. THERE IS NO CORRECTIVE ACTION NEEDED AT THIS TIME. PREVENTIVE ACTION: NO ROOT CAUSE WAS FOUND. THERE IS NO PREVENTIVE ACTION NEEDED AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

D

Patient 1

COPIED BELOW ARE RESPONSES GIVEN BY THE INITIAL REPORTER TO THE DEROYAL COMPLAINT QUESTIONNAIRE. QUALITY ISSUE DETAILS: DATE OF OCCURRENCE: (B)(6) 2016. 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: PATIENT DEVELOPED HOSPITAL ACQUIRED PRESSURE ULCER WHEN USING THIS PRODUCT. HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY ACTUAL USE. HOW WAS THE PRODUCT BEING USED? HEEL PROTECTOR. 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: NONE. PERSON(S) AFFECTED BY OUTCOME(S) CHECKED ABOVE: NONE. KNOWN PRE-EXISTING CONDITION(S) OF PERSON(S) AFFECTED: NONE SPECIFIED. WAS THE INCIDENT REPORTED TO THE FDA? DON'T KNOW. DETAILED DESCRIPTION OF OUTCOME(S), INCLUDING INFORMATION REGARDING INJURY OR ANY ADDITIONAL TREATMENT/INTERVENTION REQUIRED: PATIENT DEVELOPED HOSPITAL ACQUIRED PRESSURE ULCER. ADDITIONAL REQUEST FOR INFORMATION FROM CUSTOMER: THE INVESTIGATION TEAM FOLLOWED UP THE INITIAL COMPLAINT REPORT WITH ADDITIONAL QUESTIONS. THE QUESTIONS ARE COPIED BELOW. AT THE TIME OF THIS WRITING, NO RESPONSE WAS GIVEN MY CUSTOMER. IN ADDITION, NO COMPLAINT SAMPLES HAVE BEEN RECEIVED BY DEROYAL FOR ANALYSIS. WHERE WAS LOCATION OF THE PRESSURE ULCERS? WE WOULD LIKE TO VERIFY WHEN DID EACH OF THESE EVENTS OCCUR? WHAT TYPE OF PATIENTS DID THIS HAPPEN WITH? EX. ELDERLY, YOUNG, MIDDLE AGE, DIABETIC.