MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-22 for A&E MEDICAL MYOWIRE IIA&E MEDICAL MYOWIRE II * manufactured by Alto Development Corp.
| Report Number | 4976121 |
| MDR Report Key | 4976121 |
| Date Received | 2015-07-22 |
| Date of Report | 2015-07-22 |
| Date of Event | 2015-07-21 |
| Report Date | 2015-07-22 |
| Date Reported to FDA | 2015-07-22 |
| Date Reported to Mfgr | 2015-08-06 |
| Date Added to Maude | 2015-08-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A&E MEDICAL MYOWIRE IIA&E MEDICAL MYOWIRE II |
| Generic Name | SUTURE, NONABSORBABLE, STEEL |
| Product Code | GAO |
| Date Received | 2015-07-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 0560S |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DAY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALTO DEVELOPMENT CORP |
| Manufacturer Address | 5206 ASBURY ROAD PO BOX 758 FARMINGDALE NJ 07727 US 07727 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 2015-07-22 |