MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-10 for VAGINAL DELIVERY PACK DYNJ24851K manufactured by Medline Industries, Inc..
[72204461]
Patient Sequence No: 1, Text Type: N, H10
[72204462]
Vaginal delivery pack had 11 sponges instead of 10. Caught by nurse during counting procedure before delivery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6475174 |
| MDR Report Key | 6475174 |
| Date Received | 2017-04-10 |
| Date of Report | 2017-04-06 |
| Date of Event | 2017-03-15 |
| Report Date | 2017-03-28 |
| Date Reported to FDA | 2017-03-28 |
| Date Reported to Mfgr | 2017-03-28 |
| Date Added to Maude | 2017-04-10 |
| 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 | VAGINAL DELIVERY PACK |
| Generic Name | OBSTETRICAL KIT |
| Product Code | OKV |
| Date Received | 2017-04-10 |
| Model Number | DYNJ24851K |
| Catalog Number | DYNJ24851K |
| Lot Number | 16YB3956 |
| ID Number | 93573/9926-43 |
| Device Expiration Date | 2017-08-31 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-10 |