MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-02 for HU-FRIEDY EXCAVATOR (SUSPECTED) UNKNOWN manufactured by Hu-friedy Mfg Co., Llc.
[24876389]
Instrument not returned for evaluation. Unable to verify instrument catalog number and manufacturing date. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[24876390]
On (b)(6), during a dental procedure, the instrument tip broke and was swallowed by patient. A local anesthetic was being used at the time of the procedure. Patient was sent to the er for x-rays and scoping procedure. X-rays showed tip went into the stomach but was unable to be found during scoping procedure. On (b)(6), another x-ray was taken and showed tip had moved down into the large intestine. On (b)(6), the tip had been removed via endoscopic procedure. On (b)(6), doctor reported he saw patient again for another tooth and patient will also be getting an mri due to pain in his lower gut area where tip was previously lodged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2015-00004 |
| MDR Report Key | 5051684 |
| Date Received | 2015-09-02 |
| Date of Report | 2015-09-02 |
| Date of Event | 2015-06-10 |
| Date Mfgr Received | 2015-08-05 |
| Date Added to Maude | 2015-09-02 |
| 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 | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MARIA VRABIE |
| Manufacturer Street | 3232 N ROCKWELL ST |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7738685676 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HU-FRIEDY EXCAVATOR (SUSPECTED) |
| Generic Name | EXCAVATOR |
| Product Code | EKC |
| Date Received | 2015-09-02 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | DENTIST |
| Device Availability | N |
| 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. Hospitalization | 2015-09-02 |