MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-11-13 for REDI-FOAM MT-FA MT-FA-40B manufactured by Med-tec,inc..
[144339]
Open bottle popped and made a foam mess in sink. No one was injured and only equipment was foamed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932738-1998-00001 |
| MDR Report Key | 198173 |
| Report Source | 07 |
| Date Received | 1998-11-13 |
| Date of Report | 1998-11-13 |
| Date of Event | 1998-10-19 |
| Date Mfgr Received | 1998-10-19 |
| Date Added to Maude | 1998-11-24 |
| 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 |
| 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 | REDI-FOAM |
| Generic Name | FOAMING AGENT |
| Product Code | IWE |
| Date Received | 1998-11-13 |
| Model Number | MT-FA |
| Catalog Number | MT-FA-40B |
| Lot Number | 38 1998 |
| ID Number | * |
| Device Expiration Date | 1998-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 192526 |
| Manufacturer | MED-TEC,INC. |
| Manufacturer Address | P.O. BOX 320 ORANGE CITY IA 51041 US |
| Baseline Brand Name | REDI FOAM |
| Baseline Generic Name | FOAMING AGENT |
| Baseline Model No | MT-FA |
| Baseline Catalog No | MT-FA-40B/41B |
| Baseline ID | SUFFIXES OF 39, |
| Baseline Device Family | REDI-FOAM |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 6 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K951808 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-11-13 |