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 2018-03-13 for C8313, XXS ALEXIS WND PROT/RET 5/BX 101355501 manufactured by Applied Medical Resources.
[102586520]
No product is being returned for evaluation, but a lot # is provided. A device history report is to be reviewed by engineering. A final report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10
[102586521]
Procedure performed: unk. (b)(4) received via maude database: (b)(4). Event description: "when removing a portion of the stomach via the port site, the alexis wound protector broke. A portion of the wound protector was in the abdomen. The surgeon removed the complete broken portion that was in the abdomen. X-ray was obtained. X-ray was negative. " type of intervention: "the surgeon removed the complete broken portion that was in the abdomen. " patient status: unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2018-00103 |
| MDR Report Key | 7335029 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2018-03-13 |
| Date of Report | 2018-03-19 |
| Date of Event | 2018-01-10 |
| Date Mfgr Received | 2018-02-12 |
| Device Manufacturer Date | 2017-09-01 |
| Date Added to Maude | 2018-03-13 |
| 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 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 | C8313, XXS ALEXIS WND PROT/RET 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2018-03-13 |
| Model Number | C8313 |
| Catalog Number | 101355501 |
| Lot Number | 1306143 |
| 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 | 2018-03-13 |