MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-17 for THORACIC LUMBAR-SACRAL CORRECTIVE ORTHOSIS manufactured by Medisol Usa, Inc..
[13113]
Nursing home received new wheelchair with thoracic lumbar-sacral corrective orthosis. Pt had velcro strap around trunk and was found on 9/21/94 falling out of wheelchair with velcro undone. Representative came on 9/24/94 and recommended a different belt. On 9/25/94, resident was repositioned several times for sliding forward. Found her slid out of wheelchair - unable to release strap (too tight) and breathing restricted by strap. Lifted resident up and examined wheelchair. Front of cushion slopes down and cushion cover and part of cushion extends over seat of wheelchair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003707 |
| MDR Report Key | 16869 |
| Date Received | 1994-10-05 |
| Date of Report | 1994-10-03 |
| Date of Event | 1994-09-21 |
| Date Added to Maude | 1994-10-18 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THORACIC LUMBAR-SACRAL CORRECTIVE ORTHOSIS |
| Product Code | IPY |
| Date Received | 1994-10-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16802 |
| Manufacturer | MEDISOL USA, INC. |
| Manufacturer Address | SOUTH EL MONTE CA 91733 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-10-05 |