FDA.reportPublic FDA data

MAUDE MDR 9738187

MDR report key
9738187
Report number
9681684-2020-00014
Event key
0
Event type
3
Date of event
2020-01-29
Date received
2020-02-21
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#

Contact
KINGA STOLINSKA
Address
KS. WAWRZYNIAKA 2 KOMORNIKI 62-05 PL
Phone
688-688-6882
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MAXI SKY 2LIFT, PATIENT, NON-AC-POWEREDARJOHUNTLEIGH MAGOG INC.FSAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-2101. H; 2. R

Event Narratives#

N

Patient 1

WE ARE IN A PROCESS OF GATHERING AND REVIEWING INFORMATION REGARDING REPORTED INCIDENT . FINAL CONCLUSIONS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

D

Patient 1

IT WAS REPORTED TO AN ARJO REPRESENTATIVE THAT THERE WAS AN INCIDENT WITH THE INVOLVEMENT OF AN ARJO TOILET SLING AND MAXI SKY 2 CEILING LIFT. FOLLOWING INFORMATION PROVIDED, THE PATIENT SLIPPED OUT OF THE SLING BY ITS BOTTOM SECTION. CAREGIVER, WHO WAS PRESENT DURING TRANSFER, FAILED TO CATCH THE PATIENT. IT SEEMS LIKELY THAT THE PATIENT SLIPPED OUT DUE TO INCORRECT PLACEMENT IN THE SLING. AS THE CONSEQUENCE OF THE EVENT PATIENT FELL OFF THE SLING AND SUSTAINED LIGHT CRACK TO THE STERNUM AND WOUND AT THE HEAD. HOSPITALIZATION WAS ALSO REQUIRED WHERE BANDAGE AND IMMOBILIZATION TO HEAL THE CRACK WERE PROVIDED.