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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CAREVO
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ARJOHUNTLEIGH POLSKA SP. Z O.O. CAREVO Back to Search Results
Model Number BAC1111-01
Device Problem Use of Device Problem (1670)
Patient Problems Fall (1848); Laceration(s) (1946)
Event Date 06/05/2014
Event Type  Injury  
Event Description
It was reported by the company representative: "patient was supported from nursing staff into the shower trolley for taking a shower.To dry his back, he was moved on the left side, he kept holding at the drop side frame.The drop side frame loosened, dropped down and the patient fell down on the floor.Maybe the rear locking was not completely locked in place and patient loosened the front locking by holding himself at the side frame, so that the side frame could drop down." reference mfr # 3007420694-2014-00073.
 
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Brand Name
CAREVO
Manufacturer (Section D)
ARJOHUNTLEIGH POLSKA SP. Z O.O.
ul. ks piotra wawrzyniaka 2
komorniki PL-6 2052
PL  PL-62052
Manufacturer (Section G)
ARJO, INC.
50 north gary ave., suite a
roselle IL 60172 168
Manufacturer Contact
50 north gary ave., suite a
roselle, IL 60172-1684
MDR Report Key3952405
MDR Text Key4643016
Report Number1419652-2014-00175
Device Sequence Number1
Product Code FNG
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 07/03/2014,06/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberBAC1111-01
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/03/2014
Distributor Facility Aware Date06/06/2014
Device Age1 NA
Event Location Nursing Home
Date Report to Manufacturer07/03/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/18/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age76 YR
Patient Weight65
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