MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-02 for PHILIPS RESPIRONICS manufactured by Philips Respironics.
[99107291]
Child presented to hospital with a rash/burn to her lower back, parents suspected it was from her bill blanket. Evaluation was unable to determine exact cause of her rash/burn, mri showed large fluid collections to the lower back, pediatric surgery also seeing the baby and feel that this is also a vascular abnormality/possible hemangioma. Child was transferred to (b)(6) hospital in (b)(6). It was confirmed that this facility does have pediatric vascular anomaly team.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075046 |
| MDR Report Key | 7240937 |
| Date Received | 2018-02-02 |
| Date of Report | 2018-02-01 |
| Date of Event | 2018-01-22 |
| Date Added to Maude | 2018-02-05 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | PHILIPS RESPIRONICS |
| Generic Name | PHILIPS BILI BLANKET |
| Product Code | FMZ |
| Date Received | 2018-02-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS RESPIRONICS |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-02-02 |