MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-01-23 for GROSS TRACTION UNIT manufactured by Steris Corporation - Montgomery.
[16009980]
The user facility reported their gross traction device did not function properly during a patient procedure. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
[16287245]
The gross traction device has been sent back to steris montgomery for evaluation. 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
[30284273]
The evaluation revealed assembly errors within the gross traction device. When the unit was reassembled to specification, it was found to function normally and correctly. A review of on-hand inventory was conducted and revealed this to be an isolated event. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[30284274]
No procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2014-00007 |
| MDR Report Key | 3589475 |
| Report Source | 06 |
| Date Received | 2014-01-23 |
| Date of Report | 2014-01-23 |
| Date of Event | 2013-12-30 |
| Date Mfgr Received | 2013-12-30 |
| Date Added to Maude | 2014-04-21 |
| 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 | 2014-01-23 |
| 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 | 2014-01-23 |