MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-03-13 for MED-TEC MT-250-R-D manufactured by Med-tec, Inc..
[19492353]
Board broke with patient on breastboard. No one was hurt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932738-2002-00001 |
| MDR Report Key | 383362 |
| Report Source | 06 |
| Date Received | 2002-03-13 |
| Date of Report | 2002-03-13 |
| Date of Event | 2002-02-07 |
| Date Mfgr Received | 2002-03-08 |
| Device Manufacturer Date | 1997-01-01 |
| Date Added to Maude | 2002-03-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DONALD RIIBE |
| Manufacturer Street | 1401 8TH ST SE PO BOX 320 |
| Manufacturer City | ORANGE CITY IA 510410320 |
| Manufacturer Country | US |
| Manufacturer Postal | 510410320 |
| Manufacturer Phone | 7127378688 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MED-TEC |
| Generic Name | BREAST BOARD |
| Product Code | LHN |
| Date Received | 2002-03-13 |
| Model Number | MT-250-R-D |
| Catalog Number | MT-250-R-D |
| Lot Number | * |
| ID Number | PUR IN 1997 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 372432 |
| Manufacturer | MED-TEC, INC. |
| Manufacturer Address | 1401 8TH STREET S.E. ORANGE CITY IA 510410320 US |
| Baseline Brand Name | MED-TEC |
| Baseline Generic Name | BREAST BOARD |
| Baseline Model No | MT-250-R-D |
| Baseline Catalog No | MT-250-R-D |
| Baseline ID | PUR IN 1997 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-03-13 |