MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-11 for HARVEST TERUMO 51402 manufactured by Terumo Bct.
[82510542]
Additional product code: fmf. Investigation: per the customer, the patient was given antibiotics prophetically prior to surgery. During the procedure, blood was collected and processed, then administered to the patient without issue. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[82510543]
The customer called to report that a patient underwent a dental implant surgery on (b)(6) 2016 and was treated with platelet rich plasma (prp) product. Approximately one week post procedure, the patient developed painful swelling, exudate and redness in the jaw close to the implant. The patient re-visited the physician at the customer's site. Per physician's order, the patient was given oral antibiotics for several weeks and was released from physician care. The customer reports that the patient is improving and in healthy condition. The customer declined to provide patient's age. The apc-20 procedure pack is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2017-00323 |
| MDR Report Key | 6788795 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-11 |
| Date of Report | 2017-08-11 |
| Date of Event | 2016-11-18 |
| Date Mfgr Received | 2017-11-14 |
| Device Manufacturer Date | 2016-09-29 |
| Date Added to Maude | 2017-08-11 |
| 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 | 3 |
| Brand Name | HARVEST TERUMO |
| Generic Name | APC-20 PROCEDURE PACK |
| Product Code | ORG |
| Date Received | 2017-08-11 |
| Catalog Number | 51402 |
| Lot Number | 09Z9940 |
| ID Number | 05020583514027 |
| Device Expiration Date | 2017-09-01 |
| 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 | 2017-08-11 |