MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-03 for A4E02, PYTHON 5MM-80CM UNK manufactured by Applied Medical Resources.
[181789262]
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
[181789263]
Procedure performed: ni. Hospital: [name]. Original description received from lemaitre: "5 stuck a4e02 sind geplatzt, ein stuck ist nach entnahme aus der verpackung bereits am ballon defekt, da ballon perforiert keine lot, da keine verpackung mehr vorhanden!! ". English translation: "5 pieces of a4e02 have burst, one piece is already defective on the balloon after being removed from the packaging because the balloon is perforated no lot as there is no packaging left!! ". Description from [name], lemaitre. "5 pieces of a4e02 have burst, one piece is defective on the balloon after being removed from the packaging, because the balloon is perforated. No lot because there is no packaging left. " product will not be returned as the device has been discarded in the hospital. The lot number is unknown. [name] provided a lemaitre lot trace that includes the a4e02 catheter lot numbers that have been sent to this facility. Additional information received via phone on 19feb2020 from [name], lemaitre. It is currently unknown if this complaint refers to one device or multiple. Complaint was noticed during pre-check. Intervention: ni. Patient status: no patient injury indicated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00400 |
| MDR Report Key | 9780617 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-03 |
| 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 | A4E02, PYTHON 5MM-80CM |
| Generic Name | CATHETER, EMBOLECTOMY |
| Product Code | DXE |
| Date Received | 2020-03-03 |
| Model Number | A4E02 |
| 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 | 2020-03-03 |