MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for RESIST-A-BAND LXB5873R manufactured by Quality Latex Product Ltd (pvt).
[134399220]
.
Patient Sequence No: 1, Text Type: N, H10
[134399221]
Person was using the resist-a-band duringna group exercise class (barre-fusion) at sports club. The band broke and the person fell and broke her wrist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435946-2019-00001 |
| MDR Report Key | 8286555 |
| Date Received | 2019-01-29 |
| Date of Report | 2019-01-10 |
| Date of Event | 2018-03-15 |
| Date Facility Aware | 2019-01-08 |
| Report Date | 2019-01-10 |
| Date Reported to FDA | 2019-01-10 |
| Date Reported to Mfgr | 2019-01-10 |
| Date Added to Maude | 2019-01-29 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESIST-A-BAND |
| Generic Name | RESISTANCE BAND |
| Product Code | IOD |
| Date Received | 2019-01-29 |
| Model Number | LXB5873R |
| Catalog Number | LXB5873R |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUALITY LATEX PRODUCT LTD (PVT) |
| Manufacturer Address | HANWELLA ESTATE PAHATHGAMA, HANWELLA CE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-29 |