MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-26 for EMFIELDPRO 5032 manufactured by Zimmer Medizinsysteme Gmbh.
| Report Number | 8010720-2019-00001 |
| MDR Report Key | 9380230 |
| Date Received | 2019-11-26 |
| Date of Report | 2019-11-26 |
| Date of Event | 2019-10-28 |
| Date Mfgr Received | 2019-10-28 |
| Date Added to Maude | 2019-11-26 |
| 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. JENNIFER CLETO |
| Manufacturer Street | 4410 ROSEWOOD DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9256214130 |
| Manufacturer G1 | ZIMMER MEDIZINSYSTEME GMBH |
| Manufacturer Street | JUNKERSSTRASSE 9 |
| Manufacturer City | NEU-ULM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EMFIELDPRO |
| Generic Name | STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING |
| Product Code | NGX |
| Date Received | 2019-11-26 |
| Catalog Number | 5032 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER MEDIZINSYSTEME GMBH |
| Manufacturer Address | JUNKERSSTRASSE 9 NEU-ULM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-26 |