MAUDE Adverse Event Report: INVACARE CORP. (TW) TRANSFER BENCH; ADAPTER, HYGIENE

Model Number 9670

Device Problem Burst Container or Vessel (1074)

Patient Problems Bruise/Contusion (1754); Pain (1994); Injury (2348)

Event Date 05/26/2018

Event Type  Injury  

Event Description

While using invacare transfer bench model 9670 back of chair "popped out" causing serious injury to my wife (who was in the chair).Left shoulder sore, slight bruising.

• Brand Name: TRANSFER BENCH
• Type of Device: ADAPTER, HYGIENE
• Manufacturer (Section D): INVACARE CORP. (TW)
• MDR Report Key: 7564942
• MDR Text Key: 110099846
• Report Number: MW5077598
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9670
• Device Catalogue Number: E0248
• Device Lot Number: UNSURE
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 57