MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-02 for HEMORRHAGE OCCLUDER PIN CR 1007 * manufactured by Surgin, Inc..
[21711138]
The physician inserted the pin into sacrum to occlude a vessel, the tip went into the sacrum but the head broke off. It was retrieved with no harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 515084 |
| MDR Report Key | 515084 |
| Date Received | 2004-03-02 |
| Date of Report | 2004-03-01 |
| Date of Event | 2004-02-17 |
| Date Facility Aware | 2004-02-17 |
| Report Date | 2004-03-01 |
| Date Reported to FDA | 2004-03-01 |
| Date Reported to Mfgr | 2004-03-01 |
| Date Added to Maude | 2004-03-11 |
| 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 | 3 |
| 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 | HEMORRHAGE OCCLUDER PIN |
| Generic Name | * |
| Product Code | MBJ |
| Date Received | 2004-03-02 |
| Returned To Mfg | 2004-03-01 |
| Model Number | CR 1007 |
| Catalog Number | * |
| Lot Number | 02592C |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 504094 |
| Manufacturer | SURGIN, INC. |
| Manufacturer Address | 14762 BENTLEY CIRCLE TUSTIN CA 92780 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-03-02 |