MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-29 for HALYARD STERILIZATION WRAP O.R. DRAPE manufactured by O&m Halyard, Inc..
| Report Number | MW5088486 |
| MDR Report Key | 8842502 |
| Date Received | 2019-07-29 |
| Date of Report | 2019-07-26 |
| Date of Event | 2019-07-08 |
| Date Added to Maude | 2019-07-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HALYARD STERILIZATION WRAP O.R. DRAPE |
| Generic Name | DRAPE, SURGICAL |
| Product Code | KKX |
| Date Received | 2019-07-29 |
| Lot Number | LT9149000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | O&M HALYARD, INC. |
| Manufacturer Address | ALPHARETTA GA 30004 US 30004 |
| Brand Name | HALYARD STERILIZATION WRAP O.R. DRAPE |
| Generic Name | DRAPE, SURGICAL |
| Product Code | KKX |
| Date Received | 2019-07-29 |
| Lot Number | LT9149000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OEM HALYARD, INC. |
| Manufacturer Address | ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-29 |