MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-02-28 for G6313, L ALEXIS O C-SEC RET 5/BX 101356801 manufactured by Applied Medical Resources.
[181762961]
The event unit returned to applied medical for evaluation. A follow-up report will be provided upon completion of the investigation. Also, this report is a follow-up report for medwatch report number: mw5092808.
Patient Sequence No: 1, Text Type: N, H10
[181762962]
Name of procedure being performed: c-section. Detailed description of event: during the procedure the alexis sheath tore in the middle. It is unknown if other instruments were used within the alexis. There were no remnants from the tear. Finished case with the device and removed. All material was retrieved. There was no patient injury. Photos are not available. The device will be returned. Medwatch received via mail on 20feb2020. Medwatch report number: mw5092808. Date fda received: 05feb2020. "voluntary 06-feb-2020 12:23:28. 00: alexis o c-section protector/retractor clear plastic tore during a c-section procedure under normal use. Fda safety report id# (b)(4). " patient status: no patient injury. Type of intervention: completed the case with the same device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00395 |
| MDR Report Key | 9771891 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-02-28 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2019-09-24 |
| Date Added to Maude | 2020-02-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | G6313, L ALEXIS O C-SEC RET 5/BX |
| Generic Name | RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL |
| Product Code | KGW |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2020-02-11 |
| Model Number | G6313 |
| Catalog Number | 101356801 |
| Lot Number | 1368997 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |