MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-18 for FHC 5005L manufactured by Fhc.
[34325146]
Microtargeting electrodes were faulty and causing impedances. Removed from surgical field and replaced. Faulty devices prolonged the surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058697 |
| MDR Report Key | 5324372 |
| Date Received | 2015-12-18 |
| Date of Report | 2015-12-18 |
| Date of Event | 2015-11-04 |
| Date Added to Maude | 2015-12-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FHC |
| Generic Name | MICROTARGETING ELECTRODES |
| Product Code | GZL |
| Date Received | 2015-12-18 |
| Returned To Mfg | 2015-12-21 |
| Model Number | 5005L |
| Catalog Number | 5005L |
| Lot Number | 211561 |
| Device Expiration Date | 2018-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FHC |
| Manufacturer Address | 1201 MAIN STREET BOWDOIN ME US |
| Brand Name | FHC |
| Generic Name | MICROTARGETING ELECTRODES |
| Product Code | GZL |
| Date Received | 2015-12-18 |
| Model Number | 66-IT-300 |
| Catalog Number | 66-IT-300 |
| Lot Number | 211743 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | FHC |
| Manufacturer Address | 1201 MAIN STREET BOWDOIN ME US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-18 |