MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-18 for DENOVO PRODUCTS GEL INFANT HEEL WARMER 355NW manufactured by Denovo Products Llc.
[105797504]
Patient Sequence No: 1, Text Type: N, H10
[105797505]
The metal disc is missing from the product. The product cannot be activated as there is no metal disc inside the product to flex.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7439443 |
| MDR Report Key | 7439443 |
| Date Received | 2018-04-18 |
| Date of Report | 2018-04-10 |
| Date of Event | 2018-04-09 |
| Report Date | 2018-04-10 |
| Date Reported to FDA | 2018-04-10 |
| Date Reported to Mfgr | 2018-04-10 |
| Date Added to Maude | 2018-04-18 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENOVO PRODUCTS GEL INFANT HEEL WARMER |
| Generic Name | INFANT HEEL WARMER (CHEMICAL HEAT PACK) |
| Product Code | MPO |
| Date Received | 2018-04-18 |
| Model Number | 355NW |
| Catalog Number | 355NW |
| Lot Number | 030118A 08:25 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENOVO PRODUCTS LLC |
| Manufacturer Address | 17051 ALICO COMMERCE COURT UNIT 3 FORT MYERS FL 33967 US 33967 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-18 |