MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-26 for JEDMED - 8MM * 21-8280 manufactured by Jedmed.
[360083]
The vacuum trephine would not hold vacuum. No injury to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032207 |
| MDR Report Key | 528715 |
| Date Received | 2004-05-26 |
| Date of Report | 2004-05-19 |
| Date of Event | 2004-05-18 |
| Date Added to Maude | 2004-06-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JEDMED - 8MM |
| Generic Name | HESSBURG-BARRON VACUUM TREPHINE |
| Product Code | HRH |
| Date Received | 2004-05-26 |
| Returned To Mfg | 2004-05-19 |
| Model Number | * |
| Catalog Number | 21-8280 |
| Lot Number | 04048337 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 517909 |
| Manufacturer | JEDMED |
| Manufacturer Address | 5416 JEDMED COURT ST. LOUIS MO 631292221 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-05-26 |