MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for G98013KD manufactured by Medline Industries Inc..
[131892010]
It was reported that the customer, who has been has been paralyzed since 1992, was transferring himself into the shower on (b)(6) 2018, from his wheelchair via a transfer bench, when the customer was pulling his foot over the tub wall his foot slipped which resulted in the customer attempting to catch himself on the back of the transfer bench. When the customer grabbed the transfer bench the pins of the backrest snapped off and the customer fell to the shower floor resulting in the customer landing on his left leg causing a fracture to the extremity. The customer fractured his left leg when he fell in the shower and underwent a tibia/fibula stabilization procedure on (b)(6) 2018 that required screws and plates to be surgically implanted in his left leg. The customer reported that he has had this transfer bench for approximately eight months and continues to use the device. No additional information is available. The device was not returned for evaluation, therefore a device analysis could not be completed and a root cause could not be determined. Due to the reported incident, this medwatch is being filed. No additional information was provided. Should the sample be returned for evaluation or additional relevant information become available a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[131892011]
It was reported that the end-user experienced a fall from a transfer bench.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00138 |
| MDR Report Key | 8208071 |
| Date Received | 2019-01-02 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-12-02 |
| Date Mfgr Received | 2018-12-07 |
| Date Added to Maude | 2019-01-02 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 8476434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | BENCH,TRANSFER, COMMODE |
| Product Code | ILS |
| Date Received | 2019-01-02 |
| Catalog Number | G98013KD |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-02 |