MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-10-25 for SKILL-CARE CORP. 00671509103907 301270 manufactured by Skill-care Corp.
[18337907]
At 2200 resident was found by their nurse in their bathroom having partially slid down out of their wheelchair. Resident's self release soft belt was under their neck. Upon the nurse's assessment of the resident, patient's sweatshirt and t-shirt were wrapped around the soft belt and patient's arms were out of the sleeves of their shirt. The nurse attempted to release the belt but could not. The belt was cut by the nurse, resident released and assessed. This resident was cyanotic and not breathing. Resident expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 425707 |
| MDR Report Key | 425707 |
| Date Received | 2002-10-25 |
| Date of Report | 2002-10-25 |
| Date of Event | 2002-10-11 |
| Date Facility Aware | 2002-10-11 |
| Report Date | 2002-10-25 |
| Date Reported to FDA | 2002-10-25 |
| Date Reported to Mfgr | 2002-10-25 |
| Date Added to Maude | 2002-11-05 |
| 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 | SKILL-CARE CORP. |
| Generic Name | SOFT-BELT - SELF SIDE RELEASE BUCKLE |
| Product Code | IQB |
| Date Received | 2002-10-25 |
| Model Number | 00671509103907 |
| Catalog Number | 301270 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 414758 |
| Manufacturer | SKILL-CARE CORP |
| Manufacturer Address | 29 WELLS AVENUE YONKERS NY 10701 US |
| Baseline Brand Name | SKILL-CARE CORP. |
| Baseline Generic Name | SOFT-BELT-SELF SIDE RELEASE BUCKLE |
| Baseline Model No | 00671509103907 |
| Baseline Catalog No | 301270 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2002-10-25 |