MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-11 for SUPINE TABLE ATTACHMENT (A2) W/PAD 72201725 manufactured by Smith & Nephew, Inc..
[138655805]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[138655806]
It was reported that the plate broke off. There was patient involved, the same device was able to be used and the procedure was delayed for more than 60 minutes. No patient injury or other complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003604053-2019-00031 |
| MDR Report Key | 8410461 |
| Date Received | 2019-03-11 |
| Date of Report | 2019-06-17 |
| Date of Event | 2019-02-20 |
| Date Mfgr Received | 2019-06-13 |
| Date Added to Maude | 2019-03-11 |
| 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 | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUPINE TABLE ATTACHMENT (A2) W/PAD |
| Generic Name | APPARATUS, TRACTION, NON-POWERED |
| Product Code | HST |
| Date Received | 2019-03-11 |
| Catalog Number | 72201725 |
| 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 | 150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-11 |