MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-02 for MEDLINE LABOR AND DELIVERY KIT DYNOJ046310 manufactured by Medline Industries, Inc..
[44139318]
Patient Sequence No: 1, Text Type: N, H10
[44139319]
When staff was opening for a vaginal delivery, it was noted there were 15 lap sponges in the pack (supposed to be 10).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5623539 |
| MDR Report Key | 5623539 |
| Date Received | 2016-05-02 |
| Date of Report | 2016-04-28 |
| Report Date | 2016-04-28 |
| Date Reported to FDA | 2016-04-28 |
| Date Reported to Mfgr | 2016-04-28 |
| Date Added to Maude | 2016-05-02 |
| 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 | 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 | 3 |
| Brand Name | MEDLINE LABOR AND DELIVERY KIT |
| Generic Name | LABOR AND DELIVERY KIT |
| Product Code | OHM |
| Date Received | 2016-05-02 |
| Catalog Number | DYNOJ046310 |
| Lot Number | 16MB7489 |
| Device Expiration Date | 2016-12-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-02 |