MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for FETAL SPIRAL ELECTRODE 989803137631 manufactured by Philips Medical Systems.
[139690987]
Phone not provided. Serial number not provided. A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[139690988]
The customer reported wounds in the scalp area of newborns after the insertion of fetal monitor scalp electrodes during labor.
Patient Sequence No: 1, Text Type: D, B5
[140941251]
The customer did not retain the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2019-02249 |
| MDR Report Key | 8443665 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-13 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-03-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. ROBERT CORNING |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FETAL SPIRAL ELECTRODE |
| Generic Name | FETAL SPIRAL ELECTRODE, SINGLE |
| Product Code | HGP |
| Date Received | 2019-03-22 |
| Model Number | 989803137631 |
| Catalog Number | 989803137631 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-22 |