MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-01 for KING SEPTEMS LAD304 manufactured by King Septems.
[2941876]
King septems ref number lad-304 lot number: k120619. King septems reference number: lad-303 lot- k120618. Products labeled as sterile but color change indicators do not reflect sterility. Spoke with (b)(6) office, coordinator who instructed that the office would not collect the products. As such, we have returned them to the mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027459 |
| MDR Report Key | 2821123 |
| Date Received | 2012-11-01 |
| Date of Report | 2012-09-26 |
| Date of Event | 2012-09-26 |
| Date Added to Maude | 2012-11-07 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KING SEPTEMS |
| Product Code | LMA |
| Date Received | 2012-11-01 |
| Model Number | LAD304 |
| Lot Number | K120619 |
| Device Expiration Date | 2015-05-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KING SEPTEMS |
| Manufacturer Address | 15011 HERRIMAN BLVD. NOBELSVILLE IN 46060425 US 46060 4253 |
| Brand Name | KING SEPTEMS |
| Product Code | LMA |
| Date Received | 2012-11-01 |
| Model Number | LAD303 |
| Lot Number | K120618 |
| Device Expiration Date | 2015-05-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | KING SEPTEMS |
| Manufacturer Address | 15011 HERRIMAN BLVD. NOBELSVILLE IN 46060425 US 46060 4253 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-01 |