MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-10-20 for TYPE-S PT POSITIONING SYSTEM manufactured by Civco.
[20839282]
Pt presented for radiation therapy, an s-bar device was placed per mfr instruction on the treatment table. Pt lay down on the table with moderate force, and the device gave way causing the pt to fall. Pt sustained bump on his head and right shoulder injury. Was seen at a local emergency dept and told that his shoulder was sprained, he tore some ligaments, and had a small ac separation. A sling was placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1204464 |
| MDR Report Key | 1204464 |
| Report Source | 99 |
| Date Received | 2008-10-20 |
| Date of Report | 2008-10-07 |
| Date of Event | 2008-10-06 |
| Date Facility Aware | 2008-10-06 |
| Report Date | 2008-10-07 |
| Date Reported to FDA | 2008-10-07 |
| Date Reported to Mfgr | 2008-10-06 |
| Date Added to Maude | 2008-10-28 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TYPE-S PT POSITIONING SYSTEM |
| Generic Name | S-TYPE |
| Product Code | IWY |
| Date Received | 2008-10-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1251639 |
| Manufacturer | CIVCO |
| Manufacturer Address | 102 FIRST ST S KALONA IA 522479589 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-10-20 |