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 2017-09-07 for C8322, XS ALEXIS WND PROT/RET SHRT 5/BX 101432501 manufactured by Applied Medical Resources.
[85318564]
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
[85318565]
Procedure performed: appendectomy. Event description: "when a doctor rolled the outer ring up once, the sheath was torn. The surgeons replaced the product to new one and started over the procedure. " additional information received via email from the distributor, on (b)(6) 2017. The doctor rolled the outer ring up outward once (=inside out? ). " additional information received via email from the distributor, on (b)(6) 2017: the name of the procedure performed is appendectomy. I confirmed that other instruments didn't come in contact with the sheath. Type of intervention: replaced the product and "started over the procedure" patient status: no patient injury
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2017-01972 |
| MDR Report Key | 6850512 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-09-07 |
| Date of Report | 2017-10-23 |
| Date Mfgr Received | 2017-08-10 |
| Device Manufacturer Date | 2017-01-01 |
| Date Added to Maude | 2017-09-07 |
| 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 |
| 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 | 2017-09-07 |
| Returned To Mfg | 2017-08-31 |
| Model Number | C8322 |
| Catalog Number | 101432501 |
| Lot Number | 1287353 |
| 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 | 2017-09-07 |