MAUDE Adverse Event Report: DINESOL PLASTICS INVACARE I-FIT SHOWER CHAIR; CHAIR AND TABLE, MEDICAL

Model Number 9780

Device Problem Break (1069)

Patient Problem Wound Dehiscence (1154)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

The patient indicated that the shower chair was given to her secondhand by her brother and his wife, who had purchased it several years prior, and she had been using it since (b)(6) 2018.The reported weight of the patient is 202 pounds, which is within the weight capacity of 400 pounds for the 9780 shower chair.This shower chairs falls under a voluntary product recall that was initiated on (b)(6) 2012.A recall letter was sent to all affected customers, instructing them to discontinue use of the product.It was discovered that the supplier made a change to the material they were using in the manufacture of the shower chairs, and the material did not meet invacare's engineering specifications, which resulted in the plastic breaking/cracking.As a result, dinesol plastics is no longer used as a supplier of these shower chairs.The shower chair is pending an evaluation by invacare.Once the results are available, a supplemental record will be filed.

Event Description

The patient reported that while she was sitting on the 9780 i-fit shower chair, she felt like she was slipping, and she slowly and gingerly slid to the bottom of the tub as the shower chair broke in half.She advised that the seat of the chair broke from handle-to-handle, side-to-side, but the legs were not bent or broken.She stated that she was transported by ambulance to the er and then she was admitted to the hospital on 07/19/2018.She advised that she had previously had major surgery to her back, and the incident caused the incision to reopen, which required surgical repair.She stated that additional staples and a special anchor had to be applied to her back to keep the wound closed.

Event Description

The patient reported that while she was sitting on the 9780 i-fit shower chair, she felt like she was slipping, and she slowly and gingerly slid to the bottom of the tub as the shower chair broke in half.She advised that the seat of the chair broke from handle-to-handle, side-to-side, but the legs were not bent or broken.She stated that she was transported by ambulance to the er and then she was admitted to the hospital on (b)(6) 2018.She advised that she had previously had major surgery to her back, and the incident caused the incision to reopen, which required surgical repair.She stated that additional staples and a special anchor had to be applied to her back to keep the wound closed.

Manufacturer Narrative

The evaluation of the 9780 shower chair was completed on 08/22/2018.It was confirmed that the seat was cracked/broken into two pieces.The front portion of the seat appeared to have broken away from the rear portion, with the failure occurring in front of the round molded center of the seat and emanating outward through the handles on each side.The damage observed indicates that the front of the seat was likely overloaded.

• Brand Name: INVACARE I-FIT SHOWER CHAIR
• Type of Device: CHAIR AND TABLE, MEDICAL
• Manufacturer (Section D): DINESOL PLASTICS; 195 east park avenue; niles OH 44446
• MDR Report Key: 7794148
• MDR Text Key: 117564707
• Report Number: 1531186-2018-00007
• Device Sequence Number: 1
• Product Code: KMN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/27/2018,07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9780
• Device Catalogue Number: 9780
• Device Lot Number: 10/01/2011
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2018
• Distributor Facility Aware Date: 07/24/2018
• Device Age: 6 YR
• Event Location: Home
• Date Report to Manufacturer: 08/27/2018
• Date Manufacturer Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2461-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 92