MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-05 for HARVEST TERUMO 51404 manufactured by Terumo Bct.
[96747645]
Investigation is in-process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[96747646]
Terumo bct's sale representative reported a needle stick injury that occurred after a plateletrich plasma (prp) training session. While cleaning up post procedure, he got poked by the contaminated needle. Per terumo bct's internal procedure, he followed the medical protocol for needlestick injury. Patient's (operator) age and outcome are not available at this time. The harvest disposable set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2018-00005 |
| MDR Report Key | 7168579 |
| Date Received | 2018-01-05 |
| Date of Report | 2018-01-05 |
| Date of Event | 2017-12-13 |
| Date Mfgr Received | 2018-11-01 |
| Date Added to Maude | 2018-01-05 |
| 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 TERUMO |
| Generic Name | APC-30 PROCEDURE PACK |
| Product Code | ORG |
| Date Received | 2018-01-05 |
| Catalog Number | 51404 |
| ID Number | 05020583514041 |
| 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. Other; 2. Required No Informationntervention | 2018-01-05 |