MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-15 for HU-FRIEDY MFG. CO., LLC WPLW25 manufactured by Hu-friedy Mfg. Co., Llc.
[62536318]
Hu-friedy does not track our devices (which are mostly low risk class 1 devices) by serial number or udi, only by a lot number, which is tied to the date of manufacture. The product involved in the event does not have an expiration date. Reprocessor does not apply no concomitant medical products and therapy dates provided. Pma/510(k) is not applicable. Ind is not applicable.
Patient Sequence No: 1, Text Type: N, H10
[62536319]
A patient experienced an allergic reaction after her cheekbone was stabilized with 25 gauge stainless steel wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2016-00008 |
| MDR Report Key | 6178528 |
| Date Received | 2016-12-15 |
| Date of Report | 2016-12-15 |
| Date Mfgr Received | 2016-11-16 |
| Date Added to Maude | 2016-12-15 |
| 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 | MRS. MARIA VRABIE |
| Manufacturer Street | 3232 N ROCKWELL ST |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7738685676 |
| Manufacturer G1 | HU-FRIEDY MFG. CO., LLC |
| Manufacturer Street | 3232 N ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HU-FRIEDY MFG. CO., LLC |
| Generic Name | LIGATURE WIRE |
| Product Code | DYX |
| Date Received | 2016-12-15 |
| Model Number | WPLW25 |
| Catalog Number | WPLW25 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG. CO., LLC |
| Manufacturer Address | 3232 N ROCKWELL ST. CHICAGO IL 60618 US 60618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-15 |