FDA.reportPublic FDA data

MAUDE MDR 399117

MDR report key
399117
Report number
MW1025267
Event key
0
Event type
3
Date of event
2002-04-01
Date received
2002-06-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ENCOREKNEE IMMOBILIZERENCOREFYH*00229ENC 303NR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-06-1101. O

Event Narratives#

D

Patient 1

ADD'L INFO REC'D FROM MFR 8/20/02: ENCORE MEDICAL, L.P. SOFT GOODS DIVISION WAS UNABLE TO CONTACT THE DEVICE OPERATOR (END USER) TO UNDERSTAND THE EVENT ON THE MDR REPORT, BUT COMPLETED AN INVESTIGATION ON THE INCIDENT STATED ON MEDICAL DEVICE REPORT NUMBER MW1025267, SPLINT, EXTREMITY, NONINFLATABLE, EXTERNAL AND HAS CONCLUDED THAT THE INCIDENT SHOULD NOT BE WARRANTED AS AN MDR REPORTABLE-EVENT, WHERE THERE WAS NO INDICATION OF A SIGNIFICANT MEDICAL DEVICE ADVERSE EVENT OR PRODUCT PROBLEM. ENCORE'S INVESTIGATION CONCLUDED THAT THERE ARE TWO OUTSOURCING SUPPLIERS FOR THIS PRODUCT (KNEE IMMOBILIZER, ITEM # 00229) AND THE PRODUCT DOES MEET ALL ENCORE'S SPECS AND ITS FUNCTIONALITY. ALSO, ENCORE RECENTLY INQUIRED THIS PRODUCT AND OTHERS FROM KIMBERLY-CLARK SOFT GOODS LINE INCLUDING THEIR ENTIRE INVENTORY THAT MIGHT HAVE CONFUSED THE END USER ON THIS POSSIBILITY. DUE TO THE FACT THAT THIS INCIDENT DOES NOT CONSTITUTE OR SHOULD HAVE NOT BEEN CONSIDERED AS AN MDR REPORTABLE-EVENT, ENCORE IS REQUESTING FOR THE FDA TO REMOVE THE REPORT FROM ANY FDA DOCUMENTATION AND/OR MEDICAL DEVICE REPORTING WEBSITE.

D

Patient 1

RPTR RECEIVED AN INCORRECT AND INFERIOR PRODUCT IN A BOX WITH THE SAME CATALOG # AS BEFORE, BUT THE PRODUCT IS A DIFFERENT ONE. THE CO KEPT THE SAME CAT # BUT KEEPS PUTTING A DIFFERENT AND INFERIOR PRODUCT IN THAT SAME BOX. THIS HAS BEEN BROUGHT TO THEIR ATTENTION 4 TIMES.