MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-07 for HARVEST 51431 manufactured by Terumo Bct.
[119650714]
Investigation is in process, a follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[119650715]
The customer reported that following a bilateral adipose derived stem cell injection and a platelet rich plasma (prp) collection, both on the harvest device, the patient developed inflammation of the synovial membrane in one of the patients treated knees. The physician reported that the patient did well with his right knee but unfortunately had a lot of increasing pain and swelling in the left knee. After 1 week the physician aspirated the patients left knee and obtained 100 cc of fluid. The patient returned 4 days later again reporting knee pain. The dr. Was not able to draw anymore fluid off of the knee. At day 10, the physician attempted to aspirate but noted on ultrasound that the patient had extensive synovitis present. The physician injected 6 cc of 1% lidocaine and 12 mg of celestone steroid into the patients left knee which initially improved symptoms somewhat but the patient still continued to have pain requiring the use of a walker. Last follow-up with the physician (b)(6) 2018, the physician reported, the patient was able to stop using the walker but is still experiencing significant amount of pain. Patient weight is not available at this time. The product lot number was not able to be obtained from the customer. The harvest collection set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2018-00247 |
| MDR Report Key | 7857471 |
| Date Received | 2018-09-07 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-07-30 |
| Date Mfgr Received | 2018-11-02 |
| Date Added to Maude | 2018-09-07 |
| 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 | STEVE KERN |
| Manufacturer Street | 10810 W. COLLINS AVE. |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032392246 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HARVEST |
| Generic Name | ADI-25-01 ADIPREP PROCEDURE PACK |
| Product Code | MUU |
| Date Received | 2018-09-07 |
| Catalog Number | 51431 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO BCT |
| Manufacturer Address | LAKEWOOD CO 80215 US 80215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-07 |