MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX UNK manufactured by Applied Medical Resources.
[187060471]
No product is being returned for evaluation and no lot # has been provided to manufacturer. A follow up report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10
[187060472]
Procedure performed: lap chol. On (b)(6) 2020, the material coordinator of the hospital called me that there has been a gal leakage by a patient that was operated on (b)(6) 2020. Because of this, the hospital stops with using the ca500. Because the leakage happened after the or (not known when) there is no clip applier to return and no lot number available. Patient status: gal leakage, no more information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00444 |
| MDR Report Key | 9890539 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-16 |
| Date Added to Maude | 2020-03-27 |
| 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 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 | CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX |
| Generic Name | CLIP, IMPANTABLE |
| Product Code | FZP |
| Date Received | 2020-03-27 |
| Model Number | CA500 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Hospitalization | 2020-03-27 |