MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-29 for HEALEON HD PRP KIT 30 ML HEALPRP30 manufactured by Healeon Medical, Inc..
[146651900]
I prepared a sample of platelet-rich plasma using a commercially available medical device. The gel in the tube looked defective, and after the preparation, i was concerned that the gel could be injected into a pt. This product seems to have a quality issue and could affect pt safety. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086999 |
| MDR Report Key | 8655204 |
| Date Received | 2019-05-29 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-05-14 |
| Date Added to Maude | 2019-05-30 |
| 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 |
| 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 | HEALEON HD PRP KIT |
| Generic Name | PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING |
| Product Code | ORG |
| Date Received | 2019-05-29 |
| Model Number | 30 ML |
| Catalog Number | HEALPRP30 |
| Lot Number | 20190115 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEALEON MEDICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-29 |