MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2003-12-12 for FORCEP RD 50057220 * manufactured by Heraeus Kulzer, Inc..
[19157029]
Rubber dam forceps broke during treatment and a patient was hurt. Awaiting further details. Dentist uses the rubber dam technique quite often and so he bought several forceps over the last years. He can't really tell when he bought the forceps, which broke now. As far as sterilization is concerned there is nothing unusual: he uses a "thermodisinfector" and from time to time he uses also an autoclave. Received letter stating the forceps fractured when placing a rubber dam clamp on tooth 47. The return spring caused a massive fracture in the dental-lingual portion of a neighboring tooth (47). The damaged tooth was healthy with the exception of a small occlusal filling. It resulted in the temporary restoration of the open dentin wound with an adhesive composite. Adequate treatment with possible grated substance preservations, likely replacement with full crown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1925223-2003-00001 |
| MDR Report Key | 501348 |
| Report Source | 01 |
| Date Received | 2003-12-12 |
| Date of Report | 2003-11-22 |
| Date Facility Aware | 2003-09-11 |
| Date Mfgr Received | 2003-09-11 |
| Date Added to Maude | 2003-12-18 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHERYL ZIMMERMAN |
| Manufacturer Street | 4315 S. LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742996662 |
| Manufacturer G1 | HERAEUS KULZER, INC. |
| Manufacturer Street | 4315 S. LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORCEP RD |
| Generic Name | 57220 |
| Product Code | EJG |
| Date Received | 2003-12-12 |
| Model Number | 50057220 |
| Catalog Number | * |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 490130 |
| Manufacturer | HERAEUS KULZER, INC. |
| Manufacturer Address | 4315 SOUTH LAFAYETTE BLVD. SOUTH BEND IN 46614 US |
| Baseline Brand Name | FORCEP RD |
| Baseline Generic Name | 57220 |
| Baseline Model No | 50057220 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-12-12 |