MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2008-06-27 for manufactured by .
[7889214]
Eval - other: the sample involved in ths event is in the process of being forwarded to the mfg site. Upon completion of the investigation, a follow-up preport will be submitted. I can report that we have not had any other reports on this device lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617604-2008-00073 |
| MDR Report Key | 1073733 |
| Report Source | 06,07 |
| Date Received | 2008-06-27 |
| Date Mfgr Received | 2008-06-02 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2008-07-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | TIM MATSON |
| Manufacturer Street | 10 BOWMAN DR |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Country | US |
| Manufacturer Postal | 03431 |
| Manufacturer Phone | 6033523812 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 160 WEYMOUTH ST. |
| Manufacturer City | ROCKLAND MA 02370 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02370 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | BZT |
| Date Received | 2008-06-27 |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1040554 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-27 |