MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-09-17 for SURGICAL HANDPIECE 3555 0.559.0340 manufactured by Kaltenbach & Voigt Gmbh.
[917367]
The handpiece burned the patient's lip.
Patient Sequence No: 1, Text Type: D, B5
[8237923]
The patient was prescribed hydrocodone and given antibiotics prior to surgery for tooth extraction. Neosporin was given for the burn and the patient was instructed to continue the hydrocodone if the burn on the patient's lip was painful. The doctor's office stated that the patient was doing fine. The office staff was not following proper procedure for maintenance. Proper maintenance was discussed. The spray attachment was broken, bearings were worn and gritty, and falling apart. High debris level was present.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010493-2008-00017 |
| MDR Report Key | 1163557 |
| Report Source | 05 |
| Date Received | 2008-09-17 |
| Date of Report | 2008-08-20 |
| Date of Event | 2008-08-15 |
| Date Mfgr Received | 2008-08-20 |
| Device Manufacturer Date | 1999-07-01 |
| Date Added to Maude | 2008-09-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARI LAMBERT, MANAGER |
| Manufacturer Street | 340 EAST MAIN STREET |
| Manufacturer City | LAKE ZURICH IL 60047 |
| Manufacturer Country | US |
| Manufacturer Postal | 60047 |
| Manufacturer Phone | 8473643958 |
| Manufacturer G1 | KALTENBACH & VOIGT GMBH |
| Manufacturer Street | BISMARCKRING 39 |
| Manufacturer City | BIBERACH D-88400 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-88400 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL HANDPIECE 3555 |
| Generic Name | DENTAL HANDPIECE AND ACCESSORIES |
| Product Code | EKK |
| Date Received | 2008-09-17 |
| Returned To Mfg | 2008-08-20 |
| Model Number | 3555 |
| Catalog Number | 0.559.0340 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1192358 |
| Manufacturer | KALTENBACH & VOIGT GMBH |
| Manufacturer Address | BISMARCKRING 39 BIBERACH GM D-88400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-09-17 |