MAUDE Adverse Event Report: JIANGSU INTCO MEDICAL PRODUCTS CO., LTD. COMPASS HEALTH BRANDS; WHEELCHAIR

Model Number PAN20RFR

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 04/14/2020

Event Type  Injury  

Event Description

Patient cut her leg on the part where the legrest fits onto the wheelchair.They removed the legrest when moving her in and out of the chair.Said the hook has a sharp edge.The daughter said the mom was cut and needed stitches.Per medwatch form: my mother lives at an assistant living facility.She was attempting to get into her wheelchair (direct supply wheelchair with swinging leg rest), with the nurses aid standing next to her.The swinging foot rest was off the chair to prevent falls, exposing the locking pin and mounting pin for leg rest attachment (parts on wheelchair where foot rest clicks into place).When she sat down, the metal pins severely cut her leg in a "t" shape.She was rushed to er where she received approximately 2 dozen stitches (possibly more, doctor said she was pleased that she was able to get the skin to come back together), tetanus shot, plus antibiotics.She has significant co-morbidity (lymphedema, etc.) that will impact her ability to heal (history of minor scratches to lets very slow to heal and having complications).We do not have anything to cover the exposed metal or hinder attachment of leg rest when needed to use by my mother.I talked to the facilities pt this morning and she said that all wheelchairs have rest swings and you can push it to the side, it still swings back, getting in the way and can cause possible falls or hit the patient's foot while attempting to get in the chair or sit in the chair.

• Brand Name: COMPASS HEALTH BRANDS
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): JIANGSU INTCO MEDICAL PRODUCTS CO., LTD.; 77 yandunshan road; zhenjiang jiangsu; cn, 21213 2; CH 212132
• MDR Report Key: 10020856
• MDR Text Key: 193335254
• Report Number: 3012316249-2020-00017
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PAN20RFR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2020
• Distributor Facility Aware Date: 04/16/2020
• Device Age: 14 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention