MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-10 for AVID MEDICAL NEURO PACK VMCI024-06 manufactured by Owens And Minor Distribution, Inc. / Avid Medical Inc..
[117025698]
We have had 2 neuro kits from avid medical come with bugs in the wrappers. In one a dead mosquito was in the foam insert lot number 1306444, and in another neuro pack lot number 1306444 there was a life flea that came out of the pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079064 |
| MDR Report Key | 7776636 |
| Date Received | 2018-08-10 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-07-26 |
| Date Added to Maude | 2018-08-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | AVID MEDICAL NEURO PACK |
| Generic Name | NEURO KIT / NEUROLOGICAL TRAY |
| Product Code | OJG |
| Date Received | 2018-08-10 |
| Catalog Number | VMCI024-06 |
| Lot Number | 1306444 |
| Device Expiration Date | 2019-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS AND MINOR DISTRIBUTION, INC. / AVID MEDICAL INC. |
| Brand Name | AVID MEDICAL NEURO PACK |
| Generic Name | NEURO KIT / NEUROLOGICAL TRAY |
| Product Code | OJG |
| Date Received | 2018-08-10 |
| Catalog Number | VMCI024-06 |
| Lot Number | 1306444 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | OWENS AND MINOR DISTRIBUTION, INC. / AVID MEDICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-10 |