MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-02-01 for HU-FRIEDY 13/14L COLUMBIA UNIVERSITY CURETTE SC13/149 manufactured by Hu-friedy Mfg. Co., Llc.
[20938582]
Pt went for a routine cleaning and during the procedure the tip of the instrument ((b)(4)) broke in the pt's mouth and the pt swallowed the tip. Pt went to the hospital after the incident, the hospital performed an x-ray to confirm the tip had been swallowed and subsequently did an endoscopic procedure to remove the broken piece. Due to the age of the pt, the hospital did not want to wait to see if the tip would pass naturally and felt the need to remove it.
Patient Sequence No: 1, Text Type: D, B5
[21207370]
Weight of pt is not known, office was not able to provide the info. (b)(4) does not track our devices, which are mostly low risk class 1 devices, by serial number, only a lot # which is tied to the date of manufacture. Since the instrument was not returned we were not able to determine the lot number. The product involved in the event was a stainless steel instrument that does not have an expiration date. The device is not implanted, therefore implant/explant dates are not applicable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2011-00001 |
| MDR Report Key | 1981244 |
| Report Source | 05,06 |
| Date Received | 2011-02-01 |
| Date of Report | 2011-02-01 |
| Date of Event | 2011-01-18 |
| Date Mfgr Received | 2011-01-18 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2012-05-10 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | MARIA VRABIE, TEAM LEADER |
| Manufacturer Street | 3232 NORTH ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDY 13/14L COLUMBIA UNIVERSITY CURETTE |
| Generic Name | SC13/149 |
| Product Code | EIX |
| Date Received | 2011-02-01 |
| Model Number | SC13/149 |
| Catalog Number | SC13/149 |
| Lot Number | Z9 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG. CO., LLC |
| Manufacturer Address | CHICAGO IL 60618 US 60618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-02-01 |