MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-15 for C8404, XL ALEXIS O WND PROT/RET 5/BX UNK manufactured by Applied Medical Resources.
[129163862]
No product is being returned for evaluation and no lot # has been provided to manufacturer. A final report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10
[129163863]
Procedure performed: exploratory laparatomy. The device broke while in the patient's abdomen. The device was replaced. There was no patient injury. It is unknown if the malfunction occurred with the outer or inner ring. Unknown if the sheath tore, broke, or separated. Unknown if the device is available for return. Additional information was received via email from account manager on friday, (b)(6) 2018: don? T remember the lot number or anything and no need for replacement; all product was removed; happened while it was deployed in the abdomen and immediately noticed since our retraction was lost; we did use handheld rich retractors in addition to the ring. The malfunction was at the sheath, where the sheath connects to the green placement ring. No patient injury. All product was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2018-00427 |
| MDR Report Key | 8074337 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-15 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-10-19 |
| Date Mfgr Received | 2018-10-19 |
| Date Added to Maude | 2018-11-15 |
| 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 |
| Manufacturer G1 | APPLIED MEDICAL RESOURCES |
| Manufacturer Street | 22872 AVENIDA EMPRESSA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92688 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C8404, XL ALEXIS O WND PROT/RET 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2018-11-15 |
| Model Number | C8404 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-11-15 |