MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-08 for CORONET VACUUM TREPHINE VACUUM TREPHINE 8.5 11840-850 manufactured by Surgical Specialties Corp. Dba Angiotech.
[17724339]
No suction because tubing became disconnected and would not maintain a seal. ====================== health professional's impression======================wouldn't seal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1766270 |
| MDR Report Key | 1766270 |
| Date Received | 2010-07-08 |
| Date of Report | 2010-07-08 |
| Date of Event | 2010-07-07 |
| Report Date | 2010-07-08 |
| Date Reported to FDA | 2010-07-08 |
| Date Added to Maude | 2010-07-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORONET VACUUM TREPHINE |
| Generic Name | VACUUM TREPHINE 8.5 |
| Product Code | HRH |
| Date Received | 2010-07-08 |
| Model Number | VACUUM TREPHINE 8.5 |
| Catalog Number | 11840-850 |
| Lot Number | 092160 |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
| Manufacturer Address | 100 DENNIS DR. READING PA 19606 US 19606 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-08 |