MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-10 for CUSTOM PACK C-SECTION manufactured by Medline.
[64930049]
Custom pack c-section includes drape with pouch, seam on pouch failed and exposed provider to fluids. Therapy start date: (b)(6) 2017. Therapy end date: (b)(6) 2017. Diagnosis for reason of use: c-section procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067188 |
| MDR Report Key | 6245301 |
| Date Received | 2017-01-10 |
| Date of Report | 2017-01-10 |
| Date of Event | 2017-01-03 |
| Date Added to Maude | 2017-01-12 |
| 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 | CUSTOM PACK C-SECTION |
| Generic Name | CUSTOM PACK C-SECTION |
| Product Code | MLS |
| Date Received | 2017-01-10 |
| Lot Number | 16JK1759 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-10 |