MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-19 for PRE-KLENZ manufactured by Steris Corporation.
[90699551]
No report of injury. Steris contacted the initial reporter as stated on the received medwatch report. Steris explained that the cause of the reported event may be attributed to the bag-on-valve configuration; the bag of pre-klenz likely came unattached from the valve inside the pressurized container. This can occur when a can of product is dropped or shaken. Steris asked the reporter if she had any additional questions, concerns or information regarding the product and the reporter stated she did not. No additional issues have been reported. The pre-klenz point of use processing gel product label states: at point of use, press and dispense gel over surgical tray of instruments to ensure soils are evenly covered. Transport instruments for further processing. There is no need to rinse pre-klenz prior to automated processing. Pre-klenz point of use processing gel is not a medical device. Steris is reporting this as a reportable event due to the medwatch report received.
Patient Sequence No: 1, Text Type: N, H10
[90699552]
The user facility reported via medwatch (b)(4) that their new full can of pre-klenz would not spray at all.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937531-2017-00008 |
| MDR Report Key | 6962702 |
| Date Received | 2017-10-19 |
| Date of Report | 2017-10-19 |
| Date of Event | 2017-08-09 |
| Date Mfgr Received | 2017-09-19 |
| Date Added to Maude | 2017-10-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| Manufacturer G1 | STERIS CORPORATION |
| Manufacturer Street | 7501 PAGE AVENUE |
| Manufacturer City | ST. LOUIS MO 63133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63133 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PRE-KLENZ |
| Generic Name | PROCESSING GEL |
| Product Code | LRJ |
| Date Received | 2017-10-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 7501 PAGE AVENUE ST. LOUIS MO 63133 US 63133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-19 |