MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-13 for C8402, M ALEXIS O WND PROT/RET 5/BX 101356201 manufactured by Applied Medical Resources.
[177644140]
The event unit is anticipated to return. A follow-up report will be provided upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[177644141]
Name of procedure being performed: anp. Detailed description of event: "would like to notify you that an alexis wound retractor cat# c8204. Lot#: 1365929 expiration: 08/18/2022 tore during a procedure. " the account manager spoke with and received an email from the customer on 22nov2019. The customer reported that no patient injury occurred. The date of the event was (b)(6) 2019. Limited information was available at the time of reporting. It was unknown what instruments were in use at the time of the event. It was unknown what type of procedure was being performed. The device is available for return. Patient status: no patient injury occurred as a result of the complaint event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2019-00665 |
| MDR Report Key | 9468863 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-13 |
| Date of Report | 2020-02-21 |
| Date of Event | 2019-11-21 |
| Date Mfgr Received | 2019-11-22 |
| Device Manufacturer Date | 2019-08-19 |
| Date Added to Maude | 2019-12-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | C8402, M ALEXIS O WND PROT/RET 5/BX |
| Generic Name | PROSTHESIS, FINGER, CONSTRAINED, METAL/POLYMER |
| Product Code | KWG |
| Date Received | 2019-12-13 |
| Model Number | C8402 |
| Catalog Number | 101356201 |
| Lot Number | 1365929 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-12-13 |