MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-21 for HALYARD 42216NS manufactured by La Ada De Acuna, S. De. R. L. De C. V..
| Report Number | 1047429-2019-00011 |
| MDR Report Key | 8627707 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2019-04-26 |
| Date Added to Maude | 2019-05-21 |
| 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 | MS. NICHOLE EARLY |
| Manufacturer Street | 9000 WESTMONT DR. STONEHOUSE COMMERCE PARK |
| Manufacturer City | TOANO VA 23168 |
| Manufacturer Country | US |
| Manufacturer Postal | 23168 |
| Manufacturer Phone | 8283387568 |
| Manufacturer G1 | AVID MEDICAL, INC. |
| Manufacturer Street | 9000 WESTMONT DRIVE STONEHOUSE COMMERCE PARK |
| Manufacturer City | TOANO VA 23168 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 23168 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HALYARD |
| Generic Name | DRAPE |
| Product Code | PUI |
| Date Received | 2019-05-21 |
| Model Number | 42216NS |
| Lot Number | AC9029081 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LA ADA DE ACUNA, S. DE. R. L. DE C. V. |
| Manufacturer Address | AV. HIDALGO NO. 6 ESQ. BLVD. LUIS DONALDO COLOSIO COL.EDUCATIVA, 84093 MX 84093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-21 |