MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-07 for WHEATON SCIENCE PRODUCTS 4862 (WHEATON NO 348942) NA manufactured by Wheaton Science Products.
[39363]
On 2/3/97, distributor received a report indicating that a fire had occurred. The fire appears to have originated in a tissue culture cell roller lab incubator. The fire was contained by, and within, the incubator. There was no loss of life nor injury, however there was damage to the cell roller and incubator, and there was reported loss of product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523845-1997-00001 |
| MDR Report Key | 67635 |
| Date Received | 1997-02-07 |
| Date of Report | 1997-02-07 |
| Date of Event | 1997-02-02 |
| Date Facility Aware | 1997-02-03 |
| Report Date | 1997-02-07 |
| Date Reported to FDA | 1997-02-07 |
| Date Reported to Mfgr | 1997-02-07 |
| Date Added to Maude | 1997-02-11 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WHEATON SCIENCE PRODUCTS |
| Generic Name | BOTTLE ROLLER, TISSUE CULTURE |
| Product Code | KJC |
| Date Received | 1997-02-07 |
| Model Number | 4862 (WHEATON NO 348942) |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 67653 |
| Manufacturer | WHEATON SCIENCE PRODUCTS |
| Manufacturer Address | 1501 N 10TH ST MILLVILLE NJ 08332 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-02-07 |