MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-17 for SNAP? 125MMHG THERAPY CARTRIDGE WNDSNP manufactured by Kinetic Concepts, Inc..
| Report Number | 3009897021-2019-00081 |
| MDR Report Key | 8797841 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-17 |
| Date of Report | 2019-07-17 |
| Date of Event | 2019-06-18 |
| Date Mfgr Received | 2019-06-18 |
| Device Manufacturer Date | 2018-09-27 |
| Date Added to Maude | 2019-07-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR STEVEN JACKSON |
| Manufacturer Street | 6203 FARINON DRIVE |
| Manufacturer City | SAN ANTONIO TX 78249 |
| Manufacturer Country | US |
| Manufacturer Postal | 78249 |
| Manufacturer Phone | 2102556438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SNAP? 125MMHG THERAPY CARTRIDGE |
| Generic Name | OKO |
| Product Code | OKO |
| Date Received | 2019-07-17 |
| Model Number | WNDSNP |
| Lot Number | 5549875V001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KINETIC CONCEPTS, INC. |
| Manufacturer Address | SAN ANTONIO TX 78249 US 78249 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-17 |