MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-20 for WEBBING 377441 * manufactured by Patterson Medical/sammons Preston.
[2041024]
We used a sammons preston webbing (gait belt) #377441, two inch used to provide safety support for patients. There have been numerous complaints from staff of the webbing stretching out with any resistance against it. Due to the strectching out of the gait belt, it does not adequately support the patient. In one instance, the webbing started ripping. No patients were harmed. New brand of gait belts have been purchased.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182358 |
| MDR Report Key | 2182358 |
| Date Received | 2011-07-20 |
| Date of Report | 2011-07-20 |
| Report Date | 2011-07-20 |
| Date Reported to FDA | 2011-07-20 |
| Date Added to Maude | 2011-07-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WEBBING |
| Generic Name | 2 INCH WEBBING-GAIT TRANSFER BELT |
| Product Code | ISR |
| Date Received | 2011-07-20 |
| Model Number | 377441 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PATTERSON MEDICAL/SAMMONS PRESTON |
| Manufacturer Address | 1031 MENDOTA HEIGHTS RD. SAINT PAUL MN 55120 US 55120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-20 |