MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-17 for INVACARE I-FIT SHOWER CHAIR 9780 manufactured by Dinesol Plastics.
[117564707]
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.
Patient Sequence No: 1, Text Type: N, H10
[117564708]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2018-00007 |
| MDR Report Key | 7794148 |
| Date Received | 2018-08-17 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-07-18 |
| Date Facility Aware | 2018-07-24 |
| Report Date | 2018-08-27 |
| Date Reported to FDA | 2018-08-27 |
| Date Reported to Mfgr | 2018-08-27 |
| Date Mfgr Received | 2018-07-24 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2018-08-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2461-2012 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVACARE I-FIT SHOWER CHAIR |
| Generic Name | CHAIR AND TABLE, MEDICAL |
| Product Code | KMN |
| Date Received | 2018-08-17 |
| Model Number | 9780 |
| Catalog Number | 9780 |
| Lot Number | 10/01/2011 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DINESOL PLASTICS |
| Manufacturer Address | 195 EAST PARK AVENUE NILES OH 44446 US 44446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-08-17 |