MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-11 for HU-FRIEDY MFG. CO., LLC EXD56 manufactured by Hu-friedy Mfg. Co., Llc.
[45011197]
Visual evaluation determined the instrument was mangled and well past its life expectancy based on the wear on the working end and the manufacturing date code. The instrument also appeared to be re-tipped based on the bends of the #17 explorer not matching the shape of the hu-friedy brand. Date of birth of patient is unknown. Weight of patient is unknown. No relevant medical history. Hu-friedy does not track our devices, which are mostly low risk class 1 devices, by serial number, only a lot number which is tied to the date of manufacture. The product involved in the event does not have an expiration date. The device is not implanted. The device is not explanted. Not applicable. No concomitant medical products and therapy dates. The (a) nda number, bla number and 510 (k) number are not applicable to this class 1 device. No protocol numbers are relevant. This is not a follow-up. This is an initial report. No remedial action initiated. No correction/removal initiated.
Patient Sequence No: 1, Text Type: N, H10
[45011198]
During a standard exam, the doctor was looking for cavities and the tip of the instrument broke in the patient's mouth. The patient swallowed the tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2016-00002 |
| MDR Report Key | 5648603 |
| Date Received | 2016-05-11 |
| Date of Report | 2016-04-29 |
| Date of Event | 2016-04-05 |
| Date Mfgr Received | 2016-04-21 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2016-05-11 |
| 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 | DENTIST |
| 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 60613 |
| Manufacturer Country | US |
| Manufacturer Postal | 60613 |
| Manufacturer Phone | 7738685676 |
| Manufacturer G1 | HU-FRIEDY MFG. CO., LLC |
| Manufacturer Street | 3232 N ROCKWELL ST |
| Manufacturer City | CHICAGO IL 60613 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60613 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HU-FRIEDY MFG. CO., LLC |
| Generic Name | EXPLORER |
| Product Code | EKB |
| Date Received | 2016-05-11 |
| Returned To Mfg | 2016-04-21 |
| Model Number | EXD56 |
| Catalog Number | EXD56 |
| Lot Number | V4 |
| Operator | DENTIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG. CO., LLC |
| Manufacturer Address | 3232 N ROCKWELL ST CHICAGO IL 60613 US 60613 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2016-05-11 |