MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-09-27 for SAFETY-SOFT SECURITY BELT * MDT822125 manufactured by Medline Industries, Inc..
[160454]
Reportedly, the ties on the belt broke, and the pt fell from his wheelchair. The pt reportedly went to the emergency room observation and treatment of bruises.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-1999-00028 |
| MDR Report Key | 242565 |
| Report Source | 06 |
| Date Received | 1999-09-27 |
| Date of Report | 1999-08-27 |
| Date of Event | 1999-08-20 |
| Date Reported to FDA | 1999-09-27 |
| Date Reported to Mfgr | 1999-09-27 |
| Date Added to Maude | 1999-10-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8479492639 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFETY-SOFT SECURITY BELT |
| Generic Name | SECURITY BELT |
| Product Code | IQB |
| Date Received | 1999-09-27 |
| Returned To Mfg | 1999-09-03 |
| Model Number | * |
| Catalog Number | MDT822125 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 234998 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PL. MUNDELEIN IL 60060 US |
| Baseline Brand Name | SAFETY-SOFT SECURITY BELT |
| Baseline Generic Name | SECURITY BELT |
| Baseline Catalog No | MDT822125 |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-09-27 |