MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-07-18 for C8322, XS ALEXIS WND PROT/RET SHRT 5/BX 101432501 manufactured by Applied Medical Resources.
[114554265]
The event unit was not returned to applied medical for evaluation. In the absence of the subject device, it is difficult to determine the root cause of the event. Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
Patient Sequence No: 1, Text Type: N, H10
[114554266]
Procedure performed: unk. "the sheat attachment peeled off from the ring approximate size 1-2 cm. " "our customer mistakenly thrown the actual used product, so we can`t return for inspection. " additional information was received via email on 21jun2018 from, (b)(4), distributor. "the incident occur after placement of the product, while the doctor tried to roll up the sheath. " type of intervention: unk. Patient status: unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2018-00232 |
| MDR Report Key | 7701083 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-07-18 |
| Date of Report | 2018-07-18 |
| Date Mfgr Received | 2018-06-21 |
| Device Manufacturer Date | 2017-10-11 |
| Date Added to Maude | 2018-07-18 |
| 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 | C8322, XS ALEXIS WND PROT/RET SHRT 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2018-07-18 |
| Model Number | C8322 |
| Catalog Number | 101432501 |
| Lot Number | 1308093 |
| Device Availability | N |
| 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 | 2018-07-18 |