MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-11 for CARRIAGE RPLT ACTIVE HEEL TRAC BOOT 72204018 manufactured by Smith & Nephew, Inc..
[187747763]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[187747764]
It was reported that, during an arthroscopic hip surgery, the active heel traction boot was slipping from its positioning because the carriage was coming loose. It looks as if the screw that holds this in place was not as tight or might have rounded off. Surgery was completed with the same reported device. Surgery was not delayed as consequence of the allegation. 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 | 3003604053-2020-00005 |
| MDR Report Key | 9696407 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-11 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-02-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 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 | 3 |
| Brand Name | CARRIAGE RPLT ACTIVE HEEL TRAC BOOT |
| Generic Name | COMPONENT, TRACTION, NON-INVASIVE |
| Product Code | KQZ |
| Date Received | 2020-02-11 |
| Model Number | 72204018 |
| Catalog Number | 72204018 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-11 |