MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-12-22 for PERMADYNE PENTA L 030360 manufactured by Espe Dental Ag.
[15262227]
On 11/27/1998 a dentist called and reported an adverse event involving permadyne penta l, an impression material manufactured by espe. The dentist did an impression in a patient who was recently treated by implantology. The material did not cure and soaked into the stitches of the just removed suture. As a result of an accompanying infection two implants were rejected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-1998-00010 |
| MDR Report Key | 203769 |
| Report Source | 05 |
| Date Received | 1998-12-22 |
| Date of Report | 1998-11-27 |
| Date of Event | 1998-11-26 |
| Date Mfgr Received | 1998-11-27 |
| Device Manufacturer Date | 1998-02-01 |
| Date Added to Maude | 1998-12-30 |
| 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 | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERMADYNE PENTA L |
| Generic Name | POLYETHER BASED IMPRESSION MATERIAL |
| Product Code | EBH |
| Date Received | 1998-12-22 |
| Model Number | NA |
| Catalog Number | 030360 |
| Lot Number | FW0044233 |
| ID Number | NA |
| Device Expiration Date | 1999-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 197919 |
| Manufacturer | ESPE DENTAL AG |
| Manufacturer Address | ESPE PLATZ SEEFELD GM D-82229 |
| Baseline Brand Name | PERMADYNE PENTA L |
| Baseline Generic Name | POLYETHER BASED IMPRESSION MATERIAL |
| Baseline Model No | NA |
| Baseline Catalog No | 030360 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-12-22 |