MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-06-26 for WRX449723 manufactured by Medline Industries Inc..
[112335778]
It was reported that the customer tripped over a wheel and "caught" her right leg on a leg rest lever. The customer stated that she is not the owner or user of the transport wheelchair. Reportedly, the customer experienced a laceration to her right leg. She went to a local hospital emergency department (ed) where she received nine (9) sutures to the wound. No diagnostic exams reported. No further treatment reported. Reportedly, the customer has been followed by a specialist at a wound care center and has required daily wound cleaning and dressing changes at home. No antibiotic treatment reported. There was no sample returned to the manufacturer for evaluation. Due to the reported incident, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[112335779]
It was reported that the customer tripped over a wheel and "caught" her right leg on a leg rest lever. The customer reportedly experienced a laceration to her right leg that required nine (9) sutures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00054 |
| MDR Report Key | 7638060 |
| Report Source | CONSUMER |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-26 |
| Date of Event | 2018-05-03 |
| Date Mfgr Received | 2018-06-07 |
| Date Added to Maude | 2018-06-26 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | WHEELCHAIR,TRANSPORT, WALGREENS |
| Product Code | INM |
| Date Received | 2018-06-26 |
| Catalog Number | WRX449723 |
| Lot Number | 17070853 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| 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; 2. Deathisabilit | 2018-06-26 |