MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-18 for TREX2/WD86/ADULT/28/BH16/1255/U2222C/U67 9153653558 NA:TREX28RP TREX28RP manufactured by Invamex Manufacturing.
[179815046]
This event is being filed in an abundance of caution due to the wheelchair has not been returned for an evaluation. The dealer stated that they have the chair in quarantine, therefore, it will not be returned at this time. Medical records and pictures were requested from the dealer, however they said there are none available. Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[179815047]
The patient reported the wheel locks failed on her trex28rp wheelchair. She stated that when she sat down in the chair, it moved, and she fell, causing a hematoma on her leg. She stated she had to have surgery and wound care to resolve the hematoma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616091-2020-00009 |
| MDR Report Key | 9722038 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-18 |
| Date of Report | 2020-01-24 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2017-04-01 |
| Date Added to Maude | 2020-02-18 |
| 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 Contact | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVAMEX MANUFACTURING |
| Manufacturer Street | 102 PARQUE INDUSTRIAL MANIMEX |
| Manufacturer City | REYNOSA 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TREX2/WD86/ADULT/28/BH16/1255/U2222C/U67 9153653558 |
| Generic Name | WHEELCHAIR, MECHANICAL |
| Product Code | IOR |
| Date Received | 2020-02-18 |
| Model Number | NA:TREX28RP |
| Catalog Number | TREX28RP |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVAMEX MANUFACTURING |
| Manufacturer Address | 102 PARQUE INDUSTRIAL MANIMEX REYNOSA, TAMAULIPAS 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-02-18 |