MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-13 for T-MAX EXPOSURE SHOULDER POSITIONER 7210551 manufactured by Smith & Nephew, Inc..
[179449439]
It was reported that, during a shoulder procedure, the t-max shoulder positioner was slowly going back. The procedure was completed using bands tied around the chair and or staff holding up the chair; nevertheless, the surgery was not delayed. The patient was not harmed. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643264-2020-00079 |
| MDR Report Key | 9706850 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-13 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-02-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | HOLLY TOPPING |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123913905 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 76 S. MERIDIAN AVE. |
| Manufacturer City | OKLAHOMA CITY OK 731076512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 731076512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T-MAX EXPOSURE SHOULDER POSITIONER |
| Generic Name | ACCESSORIES, OPERATING-ROOM, TABLE (KIT) |
| Product Code | FWZ |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2020-01-31 |
| Model Number | 7210551 |
| Catalog Number | 7210551 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-13 |