MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-10-20 for SPRING ARM SM-OA91-3AS-A manufactured by Oasys Healthcare.
[30496945]
New replacement covers were sent to the facility and these have been installed onto the spring arm. Complaint #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[30496946]
One of the covers between the extension arm and spring arm manufactured by oasys) which support the amico ice 30 light fell down during surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007682310-2015-00001 |
| MDR Report Key | 5200343 |
| Report Source | USER FACILITY |
| Date Received | 2015-10-20 |
| Date of Report | 2015-10-09 |
| Date of Event | 2015-08-04 |
| Date Mfgr Received | 2015-08-04 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2015-11-04 |
| 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 Contact | AGUSTIN DE PAREDES |
| Manufacturer Street | 55 EAST WILMOT STREET |
| Manufacturer City | RICHMOND HILL, ON L4B 1A3 |
| Manufacturer Postal | L4B 1A3 |
| Manufacturer Phone | 7640800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPRING ARM |
| Generic Name | SPRING ARM |
| Product Code | KQM |
| Date Received | 2015-10-20 |
| Model Number | SM-OA91-3AS-A |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OASYS HEALTHCARE |
| Manufacturer Address | 191 MAIN ST N UXBRIDGE, ON L9P 1C3 L9P 1C3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-20 |