MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-05-17 for FETAL SPIRAL ELECTRODE 989803137631 manufactured by Philips Medical Systems.
[145398809]
Medical device: unable to confirm serial number. Initial reporter: phone not provided. A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[145398810]
The customer claimed that the spiral metal tip dislodged and embedded in newborn's head. The breakage was not noted during labor. It was found during the newborn examination that the metal spiral tip from the fetal spiral electrode was embedded into the newborns scalp, and was removed with minimal trauma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2019-03552 |
| MDR Report Key | 8619924 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-15 |
| Date Mfgr Received | 2019-05-15 |
| Date Added to Maude | 2019-05-17 |
| 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 | 3 |
| Brand Name | FETAL SPIRAL ELECTRODE |
| Generic Name | FETAL SPIRAL ELECTRODE, SINGLE |
| Product Code | HGP |
| Date Received | 2019-05-17 |
| Returned To Mfg | 2019-06-26 |
| Model Number | 989803137631 |
| Catalog Number | 989803137631 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-17 |