MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-04 for SQUISHON MATTRESS * 91017 manufactured by Children's Medical Ventures, Llc.
[5785202]
Infant transport mattress was removed from warmer and had color and composition change. The roberts valve is very easy to open. The mattress had stored in a warmer for approximately 6 months. This was noted prior to patient use and taken out of service. Contents listed as: water, non-toxic carboxy vinyl and anti-bacterial agent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4765080 |
| MDR Report Key | 4765080 |
| Date Received | 2015-05-04 |
| Date of Report | 2015-05-04 |
| Date of Event | 2015-04-24 |
| Report Date | 2015-05-04 |
| Date Reported to FDA | 2015-05-04 |
| Date Reported to Mfgr | 2015-05-12 |
| Date Added to Maude | 2015-05-12 |
| 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 | 3 |
| 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 | SQUISHON MATTRESS |
| Generic Name | MATTRESS SKIN PROTECTOR |
| Product Code | FMP |
| Date Received | 2015-05-04 |
| Model Number | * |
| Catalog Number | 91017 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHILDREN'S MEDICAL VENTURES, LLC |
| Manufacturer Address | 3000 MINUTEMAN RD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-04 |