MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-09-06 for RELIANCE SYNERGY WASHER manufactured by Steris Canada Corporation.
[2994195]
The user facility reported that water was leaking from the washer. An employee slipped on a water puddle in the vicinity of the washer and bruised her hip and felt pain in her elbow and tailbone. The employee went to the employee health department but no treatment was received. The employee returned to work that afternoon and is fine with no sustaining injuries. No procedural delays or cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[10133203]
A steris service technician inspected the washer and found a leak located on the recirculation piping. The technician repaired the leak and returned the unit to service. The unit is under steris service contract and was last serviced on (b)(4) 2012 during preventive maintenance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2012-00070 |
| MDR Report Key | 2729425 |
| Report Source | 06 |
| Date Received | 2012-09-06 |
| Date of Report | 2012-09-06 |
| Date of Event | 2012-08-14 |
| Date Mfgr Received | 2012-08-15 |
| Date Added to Maude | 2012-12-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS LINDSEY MCGOWAN |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927519 |
| Manufacturer G1 | STERIS CANADA CORPORATION |
| Manufacturer Street | 490, ARMAND-PARIS |
| Manufacturer City | QUEBEC, QUEBEC GIC8A3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | GIC 8A3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIANCE SYNERGY WASHER |
| Generic Name | WASHER |
| Product Code | LDS |
| Date Received | 2012-09-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CANADA CORPORATION |
| Manufacturer Address | 490 ARMAND-PARIS QUEBEC, QUEBEC GIC8A3 CA GIC 8A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-06 |