MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for ALEXIS O C-SECTION PROTECTOR / RETRACTOR G6313 manufactured by Applied Medical Resources Corp..
[178172641]
Alexis o c-section protector / retractor clear plastic tore during a c-section procedure under normal use. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092808 |
| MDR Report Key | 9677008 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-28 |
| Date Added to Maude | 2020-02-06 |
| 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 |
| 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 | ALEXIS O C-SECTION PROTECTOR / RETRACTOR |
| Generic Name | RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL |
| Product Code | GAD |
| Date Received | 2020-02-05 |
| Returned To Mfg | 2020-02-03 |
| Model Number | G6313 |
| Lot Number | 1368997 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |