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 2017-10-27 for C8301, S ALEXIS WND PROT/RET 5/BX 101355701 manufactured by Applied Medical Resources.
[91092402]
The event unit was returned to applied medical for evaluation. Visual inspection was performed on the event unit and the complainant's experience of the ring separating from the sheath could not be confirmed. However, engineering found four (4) small holes and a large horizontal tear in the sheath. Based on the condition of the returned unit, it is likely that the tear was caused by an instrument that punctured the sheath during the procedure. The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level. 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. This report represents the initial and final report. Based on the description of the event received, the event was deemed not reportable as it poses minimal risk to the patient. After evaluation, the event is deemed reportable.
Patient Sequence No: 1, Text Type: N, H10
[91092403]
Event description: "the sheath was separated from the ring. " additional information was received via email from sales manager, on thursday (b)(6) 2017: " the sheath on the white ring side was separated from the ring in places. The separated before use after unpacking. It was not inserted after noticing this. " type of intervention: unknown patient status: "no patient injury. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2017-02092 |
| MDR Report Key | 6985676 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-10-27 |
| Date of Report | 2017-10-27 |
| Date of Event | 2017-01-18 |
| Date Mfgr Received | 2017-08-08 |
| Device Manufacturer Date | 2016-01-01 |
| Date Added to Maude | 2017-10-27 |
| 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 | C8301, S ALEXIS WND PROT/RET 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2017-10-27 |
| Returned To Mfg | 2017-08-28 |
| Model Number | C8301 |
| Catalog Number | 101355701 |
| Lot Number | 1263157 |
| Device Expiration Date | 2019-01-12 |
| Device Availability | R |
| 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 | 2017-10-27 |