MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-03 for LAPAROSCOPY PACK PG24LALCF manufactured by Cardinal.
[66814144]
Small dead bugs found in sterile custom kit. Is the product compounded: no. Is the product over-the-counter: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067718 |
| MDR Report Key | 6308347 |
| Date Received | 2017-02-03 |
| Date of Report | 2017-02-03 |
| Date Added to Maude | 2017-02-07 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LAPAROSCOPY PACK |
| Generic Name | LAPAROSCOPY PACK |
| Product Code | FDE |
| Date Received | 2017-02-03 |
| Model Number | LAPAROSCOPY PACK |
| Catalog Number | PG24LALCF |
| Lot Number | 570929 |
| Device Expiration Date | 2019-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-03 |