MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-07-30 for M200 manufactured by Stanley Healthcare.
| Report Number | 1929691-2019-00002 |
| MDR Report Key | 8840879 |
| Report Source | CONSUMER |
| Date Received | 2019-07-30 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-04-15 |
| Report Date | 2019-05-20 |
| Date Reported to Mfgr | 2019-05-20 |
| Date Mfgr Received | 2019-05-20 |
| Date Added to Maude | 2019-07-30 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR GARTH JACK |
| Manufacturer Street | 4600 VINE STREET |
| Manufacturer City | LINCOLN NE 68503 |
| Manufacturer Country | US |
| Manufacturer Postal | 68503 |
| Manufacturer G1 | STANLEY HEALTHCARE |
| Manufacturer Street | 4600 VINE STREET |
| Manufacturer City | LINCOLN NE 68503 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68503 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | M200 |
| Generic Name | M200 |
| Product Code | KMI |
| Date Received | 2019-07-30 |
| Model Number | M200 |
| Catalog Number | M200 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANLEY HEALTHCARE |
| Manufacturer Address | 4600 VINE STREET LINCOLN NE 68503 US 68503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-30 |