MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-20 for C8501, S ALEXIS LAP SYS 6/BX 101042501 manufactured by Applied Medical Resources.
[184448077]
The event unit returned to applied medical for evaluation. A follow-up report will be provided upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[184448078]
Name of procedure being performed: na. Detailed description of event: all from medical leaders incoming inspection im#20-02app/po#20-03app: c8501 - tear in duckbill. Patient status: na. Type of intervention: na.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00430 |
| MDR Report Key | 9861243 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-12-23 |
| 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 | C8501, S ALEXIS LAP SYS 6/BX |
| Generic Name | RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL |
| Product Code | KGW |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-10 |
| Model Number | C8501 |
| Catalog Number | 101042501 |
| Lot Number | 1377540 |
| 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 |