MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-21 for G6313, L ALEXIS O C-SEC RET 5/BX 101356801 manufactured by Applied Medical Resources.
[93433467]
Applied medical has just received the event device and has been assigned to engineering for evaluation. A follow-up report will be sent upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[93433468]
Procedure performed - lower segment caesarean section. Incision size measured- 12. 5 cm. Alexis inserted and rolled down. Yellow placement ring was folded inwards, obstructing the operating field. Whilst baby was delivered, alexis came out of situ. When reinserting alexis o c section, it would not stay in place. Another alexis o c section was used. Type of intervention - another alexis o c section was used. Patient status -did a patient injury or illness occur associated with the complaint event? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2017-02120 |
| MDR Report Key | 7049734 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-21 |
| Date of Report | 2017-12-20 |
| Date of Event | 2017-10-25 |
| Date Mfgr Received | 2017-10-25 |
| Device Manufacturer Date | 2017-06-01 |
| Date Added to Maude | 2017-11-21 |
| 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 | 9497138233 |
| 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 | KGW |
| Product Code | KGW |
| Date Received | 2017-11-21 |
| Returned To Mfg | 2017-11-09 |
| Model Number | G6313 |
| Catalog Number | 101356801 |
| Lot Number | 1298996 |
| 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 | 2017-11-21 |