MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-03-18 for T-MAX SHOULDER POSITIONER 7210551F manufactured by Smith & Nephew Oklahoma City Manufacturing Site.
[3193416]
The claimant was working at (b)(6), in the surgery room as an anesthesia technician on (b)(6) 2009. A patient was being prepped for surgery and was transferred from a gurney to a surgical table when the surgical table started to collapse. (b)(6) attempted to prevent the table from collapsing and injuring the patient, and injured herself instead. Additional information confirm (b)(6) suffered back disc injury and underwent surgery.
Patient Sequence No: 1, Text Type: D, B5
[10630391]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1643264-2013-00007 |
| MDR Report Key | 3009805 |
| Report Source | 07 |
| Date Received | 2013-03-18 |
| Date of Report | 2013-02-18 |
| Date of Event | 2009-05-19 |
| Date Facility Aware | 2009-05-19 |
| Date Mfgr Received | 2013-02-18 |
| Device Manufacturer Date | 2007-03-02 |
| Date Added to Maude | 2013-03-19 |
| 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 | JASON BILOBRAM |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787491630 |
| Manufacturer G1 | OKLAHOMA CITY MANUFACTURING SITE |
| Manufacturer Street | 76 S. MERIDIAN AVE. |
| Manufacturer City | OKLAHOMA CITY OK 73107651 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 73107 6512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T-MAX SHOULDER POSITIONER |
| Generic Name | RFB, T-MAX II, SHOULDER POSITIONER |
| Product Code | GBB |
| Date Received | 2013-03-18 |
| Catalog Number | 7210551F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW OKLAHOMA CITY MANUFACTURING SITE |
| Manufacturer Address | 76 S. MERIDIAN AVE. OKLAHOMA CITY OK 73107651 US 73107 6512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-18 |