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 2020-03-20 for C8301, S ALEXIS WND PROT/RET 5/BX 100726601 manufactured by Applied Medical Resources.
[184447979]
The event unit returned to applied medical for evaluation. A follow-up report will be provided upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[184447980]
Name of procedure being performed: right hemicolectomy. Detailed description of event (b)(6). The client uses the new configuration of c8301 to take out specimen, and then the wound sheath was broken. Additional information received via email on (b)(6) 2020 from purchasing rep: the sheath tear occurred mid-procedure, "when they pick up the specimen". There were no instruments used within the alexis. The alexis was removed and replaced with a new device to complete the case. Patient status: fine. Type of intervention: ni.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00431 |
| MDR Report Key | 9861318 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-11-11 |
| Date Added to Maude | 2020-03-20 |
| 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 | C8301, S ALEXIS WND PROT/RET 5/BX |
| Generic Name | RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL |
| Product Code | KGW |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-03 |
| Model Number | C8301 |
| Catalog Number | 100726601 |
| Lot Number | 1374280 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-20 |