MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-05-06 for TMAX CAPITAL ED35-TMAXCASE manufactured by Smith & Nephew, Inc..
[18929681]
The (b)(4) (not a s&n product) operation table collapsed while the t-max was attached to it and the patient was under anesthesia at the time still on maquet table. No other information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[19068427]
There is no product being returned for investigation purposes. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1643264-2015-00012 |
| MDR Report Key | 4754252 |
| Report Source | 01,05,07 |
| Date Received | 2015-05-06 |
| Date of Report | 2015-04-08 |
| Date of Event | 2015-04-02 |
| Date Mfgr Received | 2015-04-08 |
| Date Added to Maude | 2015-06-04 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MEAGHAN ATWELL |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787491317 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| 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 | TMAX CAPITAL |
| Generic Name | T-MAX SHOULDER POSITIONER TRANSPORT CASE |
| Product Code | BWN |
| Date Received | 2015-05-06 |
| Model Number | ED35-TMAXCASE |
| Catalog Number | ED35-TMAXCASE |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 76 S. MERIDIAN AVE. OKLAHOMA CITY OK 73107651 US 73107 6512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-06 |