MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-05 for ECLIPSE PRP PRP1000-1000 manufactured by Estar Technologies Ltd..
[44514010]
Patient Sequence No: 1, Text Type: N, H10
[44514011]
Patient received scalp treatment on the top of the head using eclipse prp on (b)(6) 2016 by dr. (b)(6). About 24 hours after the procedure, the patient experienced irritation on the neck and behind the ears, the irritation turned into swelling of the lymph nodes, and fully recovered after 3 weeks. On (b)(6) 2016, (b)(6) received a procedure using eclipse prp and had an adverse reaction within about 24 hours of the procedure. The doctor applied blt (a topical anesthetic) to the scalp, the site of the treatment, to numb the area. The scalp was cleaned off prior to the procedure and the patient's prp was injected and applied to the treatment area. The lot number of prp used was lot 170116eb, with an expiration date of 2018-01. I was informed that no additional topical solution or cream was applied directly after the prp procedure. It is of value to note that the prp was used in a manner that is inconsistent with the 510(k) clearance, in an off label procedure. After about 24 hours, the patient began to develop enlarged lymph nodes behind the ears and on the neck. The irritation did not appear in the same area that was treated with prp. Eclipse was notified on (b)(6) of the adverse reaction ((b)(4)) the doctor who performed the procedure alleges this is likely an autoimmune response. Eclipse consulted with a doctor who has a large clientele of patients who undergo this same kind of treatment and this doctor indicated he has never seen or heard of anything like this before; however, he thought it might be a possibility of the patient having an autoimmune allergic reaction based on how quickly the patient reacted to the treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009032449-2016-00001 |
| MDR Report Key | 5634557 |
| Date Received | 2016-05-05 |
| Date of Report | 2016-04-26 |
| Date of Event | 2016-03-17 |
| Date Facility Aware | 2016-03-17 |
| Report Date | 2016-04-18 |
| Date Reported to FDA | 2016-04-18 |
| Date Reported to Mfgr | 2016-03-18 |
| Date Added to Maude | 2016-05-05 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | ECLIPSE PRP |
| Generic Name | ECLIPSE PRP |
| Product Code | ORG |
| Date Received | 2016-05-05 |
| Catalog Number | PRP1000-1000 |
| Lot Number | 170116EB |
| Device Expiration Date | 2018-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ESTAR TECHNOLOGIES LTD. |
| Manufacturer Address | 15 HAMERKAVA STREET HOLON HAMERKAZ, ISRAEL 58851 IS 58851 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-05 |