MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,user facilit report with the FDA on 2019-12-17 for EMPRINT CA108L1 manufactured by Covidien Lp - Superdimension Inc.
[173932486]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[173932487]
According to the reporter, post operatively, patient had small amount of haemoptysis. Ct thorax was performed and the symptom was resolved. The patient hospitalization was extended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004962788-2019-00088 |
| MDR Report Key | 9483666 |
| Report Source | CONSUMER,FOREIGN,USER FACILIT |
| Date Received | 2019-12-17 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-11-19 |
| 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 |
| 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 |