MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-24 for HOMER MAMMALOK GOLD ANGIOTECH 231050G - 20G X 5CM- manufactured by Medical Device Technologies.
[853045]
Patient underwent needle localization of the right breast. Needle found on patient's abdomen; unclear how the needle became misplaced. Case needed to be rescheduled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5006407 |
| MDR Report Key | 1034013 |
| Date Received | 2008-04-24 |
| Date of Report | 2008-04-24 |
| Date of Event | 2008-04-23 |
| Date Added to Maude | 2008-05-05 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOMER MAMMALOK GOLD ANGIOTECH |
| Generic Name | BREAST LOCALIZATION NEEDLE |
| Product Code | MIJ |
| Date Received | 2008-04-24 |
| Model Number | 231050G - 20G X 5CM- |
| Lot Number | 73231 KOZ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1003159 |
| Manufacturer | MEDICAL DEVICE TECHNOLOGIES |
| Manufacturer Address | 3600 SW 47TH AVE. GAINESVILLE FL 32608 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-04-24 |