MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2019-12-17 for EMPRINT CA108L1 manufactured by Covidien Lp - Superdimension Inc.
[182728828]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182728829]
According to the reporter, post-procedure, on (b)(6) 2019, the patient experienced 4/10 chest pain at the site of the previous right thoracotomy which much increased after ablation. Naproxen was started and it improved patient's pain. But on (b)(6) 2019, patient presented to gp (general practitioner) with chest pain and tiredness. Cxr (chest x-ray) performed showed suspected chest infection, no fever, cough or haemolysis. Started on oral antibiotics (doxycycline 7/7 and continued on amoxicillin 7/7 on-going course. Site stated post-ablation syndrome. Common terminology criteria for adverse events (ctcae) grade not added to adverse event yet. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004962788-2019-00089 |
| MDR Report Key | 9485452 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2019-12-17 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-11-11 |
| Date Mfgr Received | 2019-12-04 |
| Device Manufacturer Date | 2018-12-04 |
| Date Added to Maude | 2019-12-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | COVIDIEN LP - SUPERDIMENSION INC |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55441 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMPRINT |
| Product Code | NEY |
| Date Received | 2019-12-17 |
| Model Number | CA108L1 |
| Catalog Number | CA108L1 |
| Lot Number | 508167 |
| Device Expiration Date | 2020-04-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP - SUPERDIMENSION INC |
| Manufacturer Address | 161 CHESHIRE LANE, SUITE 100 PLYMOUTH MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-12-17 |