MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-02-18 for STRIDE RITE (ZYLOWARE) SR-1 * manufactured by Zyloware Corp..
[151091]
Pull-off nose pieces are easily pulled off by child and may be eaten or choked on. Rptr cannot verify it but believes their child may have swallowed one. Rptr finds this to be a design flaw as there is an alternative in screw-on nose pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1018178 |
| MDR Report Key | 263582 |
| Date Received | 2000-02-18 |
| Date of Report | 2000-02-18 |
| Date of Event | 2000-02-01 |
| Date Added to Maude | 2000-02-23 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | STRIDE RITE (ZYLOWARE) |
| Generic Name | PRESCRIPTION GLASSES FOR TODDLERS |
| Product Code | HQZ |
| Date Received | 2000-02-18 |
| Model Number | SR-1 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 255171 |
| Manufacturer | ZYLOWARE CORP. |
| Manufacturer Address | 11-36 46TH RD. LONG ISLAND CITY NY 11101 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-02-18 |