MAUDE Adverse Event Report: ACTIVEAID, LLC ACTIVEAID; 285 REHAB SHOWER/COMMODE CHAIR - TILT

Model Number 285

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

The chair was manufactured in september 2019 and shipped to the dealer on 09/04/2019.Dealer records indicate it was put into service on (b)(6) 2019.This is the first and only recorded issue/complaint alleging a pressure sore developed from the use of seat part number 60993.The seat has been in use since at least the year 2010 with (b)(4)distributed thru 2019.This seat has been available for use by clients in the front open or rear open position.The seat has a 5" wide slot opening, 8" wide aperture opening, 1.5" thick foam, waterfall opening design.It is a reaction injection molded urethane foam.The user had the seat positioned with the slot opening to the rear.The dealer says that the user needs the slot opening to the rear due to his bowel evacuation program.Evaluation of the photographs provided by the dealer show a wear pattern on the seat that suggest the user's left ischial tuberosity (it) is resting on the area of transition from the slot opening of the seat to the aperture opening of the seat.It also appears that the user is sacral sitting.The user has previously owned and utilized a 285 model chair with a 60993 seat for years before obtaining the new 285 and 60993 seat in (b)(6) without this issue occuring.That chair was at least 5-6 years old (per the dealer).The design of the seat is the same, however the formulation of the foam changed in 2016 due to regulation changes.The seat that the user had on their prior chair would be from the previous formulation.Since the formulation change in 2016 more than (b)(4) seats have been distributed.The dealer commented that the current 60993 seat feels softer than the previous 60993 seat.During discussions it was learned that the user had developed a pressure sore after spending time in respite care.Upon returning home and using the older 285 chair, the sore did not become worse.When offered a seat style with a larger opening so that the its would float and not have pressure on them, the dealer's opinion is that with the client's skin, it would be better to keep support underneath the its to lessen the chance of the skin pulling and tearing.With that, it is believed that the issue is a client/product incompatibility problem and that the new formulation of the seat may not be the correct fit for the client any longer.The user was provided with a complete new chair manufactured in november 2019.After discussions with the dealer, the new chair was assembled using seat part number 60913 which has a 5.25" wide slot opening, 8" wide aperture opening, 2" thick foam, waterfall opening design.It is a armacell mlc black and pfc elastomeric closed cell foam with a polysan liquid powder coating.The dealer is going to have the client continue to use the gel pad on top of the seat.As the foam on this new seat may be softer than the current seat part number.The package was shipped on 11/22/2019.The dealer has agreed to return the used chair for evaluation once the new chair was received.

Event Description

Activeaid customer service received a phone call from a dealer on friday november 1, 2019 regarding an issue with a seat on a model 285 shower/commode chair.The dealer stated that the customer is experiencing sores on their left buttock allegedly from the seat.Quality management contacted the dealer and received the following further information.The dealer said the shower/commode chair was put into service on (b)(6) 2019 and the customer noticed that the seat foam began compressing within the first week of (b)(6).The pressure sore developed within the second week of (b)(6) and treatment started in the third week as a stage ii ulcer and a duoderm pad with silvadene cream was prescribed.The dealer also said that a gel pad was supplied and used on the seat allowing the wound to heal.

• Brand Name: ACTIVEAID
• Type of Device: 285 REHAB SHOWER/COMMODE CHAIR - TILT
• Manufacturer (Section D): ACTIVEAID, LLC; 101 activeaid road; redwood falls MN 56283
• Manufacturer (Section G): ACTIVEAID, LLC; 101 activeaid road; redwood falls MN 56283
• Manufacturer Contact: amy curtis ; 101 activeaid raod; redwood falls, MN 56283 ; 5076442951
• MDR Report Key: 9384242
• MDR Text Key: 187259715
• Report Number: 2126684-2019-00003
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 285
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 74