MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-11-15 for NORTH COAST MEDICAL INC NC 19300-6 * manufactured by North Coast Medical Inc..
[200455]
Resident found in bed chewing at edge of soft splint located on right arm. Splint had slid down to resident's fingers. Resident chewing, broke zipper open. Resident was covered with styrofoam beads approx 1/2 cm in size. Resident had these beads in her mouth, ears, eyes, hair and clothing. Beads were removed from mouth, ears, eyes, hair and clothing. Upon ear exam one bead was inside ear canal. Physician came 11/13 and removed bead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020437 |
| MDR Report Key | 305057 |
| Date Received | 2000-11-15 |
| Date of Report | 2000-11-14 |
| Date of Event | 2000-11-12 |
| Date Added to Maude | 2000-11-20 |
| 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 | NORTH COAST MEDICAL INC |
| Generic Name | SOFT SPLINT XX-LARGE |
| Product Code | FYH |
| Date Received | 2000-11-15 |
| Returned To Mfg | 2000-11-13 |
| Model Number | NC 19300-6 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 295228 |
| Manufacturer | NORTH COAST MEDICAL INC. |
| Manufacturer Address | 18305 SUTTER BLVD MORGAN HILL CA 950372845 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-11-15 |