FDA.reportPublic FDA data

MAUDE MDR 8344034

MDR report key
8344034
Report number
2438477-2019-00003
Event key
0
Event type
3
Date of event
2019-01-02
Date received
2019-02-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
501
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DRIVEGRAB BARUNKNOWNILSRTL13083* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-1501. R

Event Narratives#

D

Patient 1

(B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A GRAB BAR. THE END-USER ACQUIRED THE DEVICE FOR ASSISTANCE IN AND OUT OF BATHTUB. SHE WAS USING THE DEVICE PRIOR TO UNDERGOING A TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2018. THE PRODUCT DETACHED FROM WALL WHILE END USER WAS GETTING OUT OF THE SHOWER. THE PATIENT WAS DIAGNOSED WITH TORN PATELLAR TENDON WHICH REQUIRED SURGERY AND A KNEE BRACE FOR 8 WEEKS. THIS PROCEDURE TOOK PLACE ON (B)(6) 2019.