MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-15 for PROLYSTICA manufactured by Steris Corporation.
[70315752]
The complainant declined to provide the injured individual contact information or product information to steris. Steris instructed the complainant to have the user follow the safety data sheet (sds) for the product. Due to the complainants refusal to provide contact or product information, steris is unable to obtain additional details; specifically, if the user sought or received medical treatment. We have been unable to obtain additional information regarding the reported event and therefore filing this report as we cannot determine if the event meets the reporting criteria outlined in 21 cfr 803. A follow-up report will be filed should we receive additional information.
Patient Sequence No: 1, Text Type: N, H10
[70315753]
A complainant contacted steris stating an individual spilled prolystica on themselves and obtained burns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937531-2017-00005 |
| MDR Report Key | 6407726 |
| Date Received | 2017-03-15 |
| Date of Report | 2017-03-15 |
| Date of Event | 2017-02-23 |
| Date Mfgr Received | 2017-02-23 |
| Date Added to Maude | 2017-03-15 |
| 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 | 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 |
| 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 | PROLYSTICA |
| Generic Name | CLEANER |
| Product Code | FLG |
| Date Received | 2017-03-15 |
| 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 | 1. Other | 2017-03-15 |