MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-01 for HALYARD WRAP-FOLD manufactured by Halyard Health, Inc. / Avanos Medical Inc..
[116047185]
Halyard one step quick check wrap and halyard wrap smart-fold - used to wrap surgical instrument trays for sterilization; found to have slits and holes in the material of over 30 wrappers over the course of several months ((b)(6) 2018 - (b)(6) 2018).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078786 |
| MDR Report Key | 7742696 |
| Date Received | 2018-08-01 |
| Date of Report | 2018-07-30 |
| Date of Event | 2018-07-30 |
| Date Added to Maude | 2018-08-02 |
| 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 |
| 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 WRAP-FOLD |
| Generic Name | STERILIZATION WRAP |
| Product Code | FRG |
| Date Received | 2018-08-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH, INC. / AVANOS MEDICAL INC. |
| Manufacturer Address | ALPHARETTA GA 30004 US 30004 |
| Brand Name | HALYARD ONE STEP QUICK CHECK WRAP |
| Generic Name | STERILIZATION WRAP |
| Product Code | FRG |
| Date Received | 2018-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH, INC. |
| Manufacturer Address | ALPHARETTA GA 30004 US 30004 |
| Brand Name | HALYARD WRAP-FOLD |
| Generic Name | STERILIZATION WRAP |
| Product Code | FRG |
| Date Received | 2018-08-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH, INC. |
| Manufacturer Address | ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-01 |