MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-08-15 for FEATHERLITE FLOOD SOURCE MED3709 manufactured by North American Scientific.
[893306]
The handle for a flood source shielded case became detached while the technician was transferring the source and case to the (b) (4) camera. The case fell on her calf. The injured technician walked to the er for treatment. She was given pain medication; her leg was wrapped in an ace bandage and ice, and was told to stay off her feet for long periods. The er report warns that muscle contusions cause bleeding in the deep tissues that can increase the pressure in the extremity. It also states that there is a small chance that the pressure from the bleeding and swelling will interfere with the circulation. If this happens, permanent damage to the muscle can occur within 4-8 hours if untreated.
Patient Sequence No: 1, Text Type: D, B5
[8107102]
While the manufacturer believes the likelihood of serious injury from a recurrence of this event is remote, the following actions have been taken. The vendor's inspection of the returned shielding case showed that the bond on one of the hinge attachments was inadequate. It is believed that when the first hinge joint failed, excessive force was placed on the remaining hinge joints resulting in the failure. The vendor has implemented a secondary bonding step during final manufacturing process using a low viscosity wicking adhesive to ensure that all hinge points are properly bonded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029030-2008-00001 |
| MDR Report Key | 1120112 |
| Report Source | 06 |
| Date Received | 2008-08-15 |
| Date of Report | 2008-08-15 |
| Date of Event | 2008-07-16 |
| Date Mfgr Received | 2008-07-18 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2010-04-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LEIGH SPOTTEN |
| Manufacturer Street | 20200 SUNBURST STREET |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8187348600 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEATHERLITE FLOOD SOURCE |
| Generic Name | NORTH AMERICAN SCIENTIFIC |
| Product Code | IXD |
| Date Received | 2008-08-15 |
| Returned To Mfg | 2008-08-06 |
| Model Number | MED3709 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTH AMERICAN SCIENTIFIC |
| Manufacturer Address | NORTH HOLLYWOOD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-08-15 |