MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-10-17 for BACTISWAB * 12100/12110 manufactured by Remel , Inc..
[729257]
The nurse pulled the product from the storage area. She removed the exterior packaging and noticed there was mold growing on the swab. The product was never used on a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 946711 |
| MDR Report Key | 946711 |
| Date Received | 2007-10-17 |
| Date of Report | 2007-10-17 |
| Date of Event | 2007-10-10 |
| Report Date | 2007-10-17 |
| Date Reported to FDA | 2007-10-17 |
| Date Added to Maude | 2007-11-15 |
| 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 | 0 |
| 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 | BACTISWAB |
| Generic Name | SWAB, BACTERIA SAMPLE |
| Product Code | JSL |
| Date Received | 2007-10-17 |
| Model Number | * |
| Catalog Number | 12100/12110 |
| Lot Number | 538508 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 918796 |
| Manufacturer | REMEL , INC. |
| Manufacturer Address | 12076 SANTA FE DRIVE P.O. BOX 14428 LENEXA KS 66215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-17 |