MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-07-15 for HALYARD* STANDARD BACK TABLE COVER-NO-44 X 78-44 X 78-SOFT FOLD-HANDI-BIN 42216NS 104221600 manufactured by O&m Halyard, Inc..
| Report Number | 3005997949-2019-00005 |
| MDR Report Key | 8789017 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-07-15 |
| Date of Report | 2019-07-30 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2019-07-30 |
| Device Manufacturer Date | 2019-01-29 |
| Date Added to Maude | 2019-07-15 |
| 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 | MR. SCOTT MCKENTLY |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485926 |
| Manufacturer G1 | AVENT SA DE R.L. DE C.V. (AVENT 3) |
| Manufacturer Street | AV. HIDALGO NO. 6 ESQ. BLVD. LUIS DONALDO COLOSIO |
| Manufacturer City | NOGALES, 84093 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 84093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HALYARD* STANDARD BACK TABLE COVER-NO-44 X 78-44 X 78-SOFT FOLD-HANDI-BIN |
| Generic Name | EQUIPMENT COVERS |
| Product Code | PUI |
| Date Received | 2019-07-15 |
| Returned To Mfg | 2019-05-06 |
| Model Number | 42216NS |
| Catalog Number | 104221600 |
| Lot Number | AC9029081 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | O&M HALYARD, INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-15 |