MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-08 for 10% NEUTRAL BUFFERED FORMALIN CONTAINER * manufactured by Statlab Medical Products, Inc..
[4687202]
Unopened formalin container that was noted to have debris floating in it. Not opened and not used for any patient specimens.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3853100 |
| MDR Report Key | 3853100 |
| Date Received | 2014-05-08 |
| Date of Report | 2014-05-08 |
| Date of Event | 2014-05-06 |
| Report Date | 2014-05-08 |
| Date Reported to FDA | 2014-05-08 |
| Date Reported to Mfgr | 2014-06-06 |
| Date Added to Maude | 2014-06-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 10% NEUTRAL BUFFERED FORMALIN CONTAINER |
| Generic Name | DEVICE, SPECIMEN COLLECTION |
| Product Code | HHT |
| Date Received | 2014-05-08 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 29299 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STATLAB MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 407 INTERCHANGE STREET MCKINNEY TX 75071 US 75071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-08 |