MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-09 for C-SECTION PACK HSAM00405 manufactured by Avid Medical.
[69893988]
A cesarean pack was opened and there was moisture found to be in the blood tube, and the towels and lap sponges were damp. Due to wetness/moisture present, the sterility of the pack was compromised. All packs from lot number were pulled and hospital supply company was notified. An avid medical complaint form was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068407 |
| MDR Report Key | 6399106 |
| Date Received | 2017-03-09 |
| Date of Report | 2017-03-09 |
| Date of Event | 2017-02-14 |
| Date Added to Maude | 2017-03-13 |
| 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 | C-SECTION PACK |
| Generic Name | OBSTETRICAL KIT |
| Product Code | OKV |
| Date Received | 2017-03-09 |
| Returned To Mfg | 2017-02-17 |
| Catalog Number | HSAM00405 |
| Lot Number | 1218060 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVID MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-09 |