MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-08-02 for RBI2 manufactured by .
[50909672]
This is a retrospective report from 2015. Incident happened in the (b)(6) and was reported by hospital 6 months after incident date.
Patient Sequence No: 1, Text Type: N, H10
[50909673]
Post biopsy bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005921952-2016-00001 |
| MDR Report Key | 5839102 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-08-02 |
| Date of Report | 2016-08-02 |
| Date of Event | 2014-11-01 |
| Date Mfgr Received | 2015-05-21 |
| Date Added to Maude | 2016-08-02 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR PAUL ZADOW |
| Manufacturer Street | 3 CHARLES STREET |
| Manufacturer City | ALLENBY GARDENS, SOUTH AUSTRALIA 5009 |
| Manufacturer Country | AS |
| Manufacturer Postal | 5009 |
| Manufacturer Phone | 83466400 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RBI2 |
| Generic Name | RBI2 SUCTION RECTAL BIOPSY SYSTEM, |
| Product Code | FCK |
| Date Received | 2016-08-02 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-02 |