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 |