MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-12 for CHS C-SECTION PLUS II DYNJCH0B03 manufactured by Medline.
[114016748]
Small piece of wood found on sterile lap within a cesarean section pack. Package discarded. Picture of foreign object taken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078349 |
| MDR Report Key | 7685078 |
| Date Received | 2018-07-12 |
| Date of Report | 2018-06-28 |
| Date of Event | 2018-06-27 |
| Date Added to Maude | 2018-07-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CHS C-SECTION PLUS II |
| Generic Name | CHS C-SECTION PLUS II |
| Product Code | OHM |
| Date Received | 2018-07-12 |
| Catalog Number | DYNJCH0B03 |
| Lot Number | 17KB8209 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-12 |