MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-02 for HU-FRIEDY #9 DEAN SCISSORS S9 manufactured by Hu-friedy Mfg. Co., Llc.
[107186486]
There is no relevant history. 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. In this instance, the lot number is was not provided by the initial reporter. The device involved in the event does not have an expiration date. The device is not implanted, therefore implant/explant dates are not applicable. No known concomitant medical products and therapy dates. Pma/510(k) is not applicable. The device manufacture date is unknown.
Patient Sequence No: 1, Text Type: N, H10
[107186487]
It was reported to hu-friedy co. , llc that during an oral surgery procedure, the instrument broke in the patient's mouth. The broken tip was swallowed. The broken tip was later retrieved from the small intestine using an endoscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2018-00003 |
| MDR Report Key | 7481761 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-02 |
| Date of Report | 2018-07-20 |
| Date of Event | 2018-04-02 |
| Date Mfgr Received | 2018-04-02 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2018-05-02 |
| 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 | 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 | 3 |
| Brand Name | HU-FRIEDY #9 DEAN SCISSORS |
| Generic Name | SCISSORS, SURGICAL TISSUE, DENTAL |
| Product Code | EGN |
| Date Received | 2018-05-02 |
| Returned To Mfg | 2018-06-15 |
| Model Number | S9 |
| Catalog Number | S9 |
| Lot Number | 0510 |
| Operator | DENTIST |
| Device Availability | R |
| Device Age | DA |
| 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 60618 US 60618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2018-05-02 |