MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-01-09 for MDS808210TC3 manufactured by Medline Industries Inc..
[132505980]
It was reported that while at home, end-user was sitting on the transport chair and end user's husband was pushing the transport chair from the kitchen to the living room. Reportedly, both the push handles of the transport chair broke. The end user's husband stated that he fell onto end-user, and then onto his knees, and used his both hands to support his balance. Per report, end user's husband was taken by emergency medical services to the emergency department where he had x-rays and he was told he broke his left wrist. A splint was reportedly placed and end user's husband followed-up with an orthopedic doctor who placed a cast to the broken left wrist. Due to the reported incident and required medical intervention, this medwatch is being filed. The sample is not available to be returned for evaluation. Pictures of the transport chair were provided. The complaint is confirmed. A root could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[132505983]
It was reported that while end user's husband was pushing the transport chair, both push handles of the transport chair broke. The end user's husband sustained left wrist fracture that required placement of cast.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00153 |
| MDR Report Key | 8231070 |
| Report Source | CONSUMER |
| Date Received | 2019-01-09 |
| Date of Report | 2019-01-09 |
| Date of Event | 2018-12-14 |
| Date Mfgr Received | 2018-12-17 |
| Date Added to Maude | 2019-01-09 |
| 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 | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | WHEELCHAIR,TRANSPORT,2TONE COSTCO ONLY |
| Product Code | INM |
| Date Received | 2019-01-09 |
| Catalog Number | MDS808210TC3 |
| Operator | HEALTH PROFESSIONAL |
| 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 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-09 |