MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-05 for WIRE manufactured by .
[2923650]
.
Patient Sequence No: 1, Text Type: D, B5
[10284746]
(b)(4). Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided. Manufacturing records could not be reviewed without a lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-02165 |
| MDR Report Key | 2814715 |
| Report Source | 05,06 |
| Date Received | 2012-10-05 |
| Date of Report | 2012-09-06 |
| Date Mfgr Received | 2012-09-06 |
| Date Added to Maude | 2012-11-02 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JODI TEMPLE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WIRE |
| Generic Name | WIRE |
| Product Code | DZK |
| Date Received | 2012-10-05 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-10-05 |