MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-12-12 for GREENE BIOPSY NEEDLE SET N/A DGBS-100 manufactured by Cook Inc.
[170967190]
Common device name: device, percutaneous, biopsy. Procode: mjg. Occupation: purchasing. Pma/ 510(k) #: exempt. (b)(4). A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[170967191]
It was reported an unknown patient required a greene biopsy needle set for an unknown procedure. During the procedure, the needle left a "small shard" inside the patient. Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-03098 |
| MDR Report Key | 9460482 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-12-12 |
| Date of Report | 2020-03-18 |
| Date of Event | 2019-11-27 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-09-10 |
| Date Added to Maude | 2019-12-12 |
| 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 | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GREENE BIOPSY NEEDLE SET |
| Product Code | MJG |
| Date Received | 2019-12-12 |
| Model Number | N/A |
| Catalog Number | DGBS-100 |
| Lot Number | 9875230 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-12-12 |