MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for AHTB ACTIVE HEEL TRACTION BOOT 72202682 manufactured by Smith & Nephew, Inc..
[141334277]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[141334278]
It was reported that during the procedure, the glue on the boot where the velcro was placed has come loose from the boot and the inner boot is moving while the patient? S foot is inside. They said that once almost the patient? S foot fell off during the surgery but there were no injuries. The procedure was finished with the same device with no delays.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003604053-2019-00043 |
| MDR Report Key | 8491945 |
| Date Received | 2019-04-08 |
| Date of Report | 2019-07-12 |
| Date Mfgr Received | 2019-07-10 |
| Date Added to Maude | 2019-04-08 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | AHTB ACTIVE HEEL TRACTION BOOT |
| Generic Name | APPARATUS, TRACTION, NON-POWERED |
| Product Code | HST |
| Date Received | 2019-04-08 |
| Returned To Mfg | 2019-04-16 |
| Catalog Number | 72202682 |
| 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 | 150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-08 |