MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-08-22 for GROSS TRACTION UNIT manufactured by Steris Corporation - Montgomery.
[15806539]
The user facility reported their gross traction device did not function properly during a patient procedure. No injuries or procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[16063853]
The investigation of this event is currently in process. A follow-up report will be submitted once additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[25237348]
The user facility reported that during a patient procedure, the gross traction unit slipped from the setting in which it was engaged. The or staff reset the gross traction unit to the desired traction setting and the procedure was completed without further issues. The user facility was given a replacement unit so that the unit subject of the event could be evaluated. No issues have been reported with the replacement unit. The gross traction unit subject of the reported event was returned to steris for evaluation. The results of the evaluation revealed the reported event was caused by loose screws in the rack assembly. The rack was adjusted, the screws were re-tightened, and the issue was corrected. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043572-2014-00082 |
| MDR Report Key | 4031470 |
| Report Source | 06 |
| Date Received | 2014-08-22 |
| Date of Report | 2014-08-22 |
| Date of Event | 2014-07-23 |
| Date Mfgr Received | 2014-07-24 |
| Date Added to Maude | 2014-09-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Street | 2720 GUNTER PARK DRIVE EAST |
| Manufacturer City | MONTGOMERY AL 36109 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 36109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GROSS TRACTION UNIT |
| Generic Name | TABLE ACCESSORY |
| Product Code | JEB |
| Date Received | 2014-08-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Address | 2720 GUNTER PARK DRIVE EAST MONTGOMERY AL 36109 US 36109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-22 |