MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-05-28 for CHILD SQUISHON 2 * manufactured by Children's Medical Ventures.
[18327316]
Product leaking from shell. Gel is yellow colored with areas that appear like mold. Sent 3 back to the co.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025174 |
| MDR Report Key | 397218 |
| Date Received | 2002-05-28 |
| Date of Report | 2002-05-24 |
| Date Added to Maude | 2002-06-04 |
| 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 | RISK MANAGER |
| 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 | CHILD SQUISHON 2 |
| Generic Name | GEL FILLED PILLOW |
| Product Code | FRP |
| Date Received | 2002-05-28 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | ITEM# 91033-204-02 |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 386271 |
| Manufacturer | CHILDREN'S MEDICAL VENTURES |
| Manufacturer Address | 275 LONG WATER DR NORWELL MA 02061 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-05-28 |