MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-20 for GRHS CUSTOM C-SECTION PACK GICS36D 2 manufactured by American Contract Systems.
[145836942]
Hair found in pack when setting up for scheduled c-section. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086790 |
| MDR Report Key | 8627878 |
| Date Received | 2019-05-20 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-05-08 |
| Date Added to Maude | 2019-05-21 |
| 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 | GRHS CUSTOM C-SECTION PACK |
| Generic Name | CESAREAN SECTION TRAY |
| Product Code | OHM |
| Date Received | 2019-05-20 |
| Model Number | GICS36D 2 |
| Lot Number | 935191 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN CONTRACT SYSTEMS |
| Manufacturer Address | MINNEAPOLIS MN 55437 US 55437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-20 |