MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-05-05 for BODYFIX P10104-821 manufactured by Medical Intelligence Medizintechnik Gmbh.
[446781]
Pt. Received 2nd of 3 radiotherapy fractions using the total body cushion for positioning. After treatment pt. Wanted to get up from the table and had new right foot drop (later information from hospital stated left foot drop). Pt. Encountered a bruising and swelling of lower leg area. Pt. Was fitted with a leg brace (later information from hospital stated bruising and swelling occurred two days later).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710332-2006-00001 |
| MDR Report Key | 709456 |
| Report Source | 06 |
| Date Received | 2006-05-05 |
| Date of Report | 2006-04-28 |
| Date of Event | 2006-03-04 |
| Report Date | 2006-05-04 |
| Date Reported to Mfgr | 2006-04-04 |
| Date Mfgr Received | 2006-04-04 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2006-05-10 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | FEYERABENDSTRASSE 13-15 |
| Manufacturer City | SCHWABMUENCHEN 86830 |
| Manufacturer Country | GM |
| Manufacturer Postal | 86830 |
| Manufacturer Phone | 232969220 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BODYFIX |
| Generic Name | BODYFIX 14 BLUEBAG TOTAL BODY |
| Product Code | LHN |
| Date Received | 2006-05-05 |
| Model Number | NA |
| Catalog Number | P10104-821 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 698500 |
| Manufacturer | MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
| Manufacturer Address | * SCHWABMUENCHEN GM |
| Baseline Brand Name | BODYFIX |
| Baseline Generic Name | BODYFIX 14 BLUEBAG TOTAL BODY |
| Baseline Model No | NA |
| Baseline Catalog No | P10104-821 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2006-05-05 |