Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROACTIVE MEDICAL PRODUCTS FULL BODY SLING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PROACTIVE MEDICAL PRODUCTS FULL BODY SLING Back to Search Results
Model Number 30112
Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Patient Problem Death (1802)
Event Date 05/09/2019
Event Type  Death  
Event Description
While transferring (b)(6) from chair to bed using a mechanical lift, the straps on the left side of the lift sling tore and she fell to the floor.(b)(6) experienced a laceration to the head, skin tear on the left arm, and probable left hip fracture.She was sent to the emergency dept for evaluation and discharged from the facility.Full extent of injuries was unk due to restricted assess to hosp medical info but a granddaughter of (b)(6)'s informed the facility on may 17, 2019 that (b)(6) expired at the hosp on (b)(6) 2019.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FULL BODY SLING
Type of Device
FULL BODY SLING
Manufacturer (Section D)
PROACTIVE MEDICAL PRODUCTS
270 washington street
mount vernon NY 10553
MDR Report Key8640199
MDR Text Key146099326
Report Number8640199
Device Sequence Number1
Product Code FSA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 05/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number30112
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/17/2019
Distributor Facility Aware Date05/09/2019
Event Location Nursing Home
Date Report to Manufacturer05/17/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization;
Patient Age79 YR
Patient Weight95
-
-