MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-15 for TRI-LAYER AAMI 2 69190 manufactured by Halyard Health, Inc..
[59920143]
Patient Sequence No: 1, Text Type: N, H10
[59920144]
The nurse was attempting to don an isolation gown. They noted the right arm of gown where sleeve meets shoulder was sewn closed, so they were unable to place their arm in the sleeve of the gown. We checked several other gowns from this lot and the same issue was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6102917 |
| MDR Report Key | 6102917 |
| Date Received | 2016-11-15 |
| Date of Report | 2016-08-31 |
| Date of Event | 2016-08-29 |
| Report Date | 2016-08-31 |
| Date Reported to FDA | 2016-08-31 |
| Date Reported to Mfgr | 2016-08-31 |
| Date Added to Maude | 2016-11-15 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | TRI-LAYER AAMI 2 |
| Generic Name | NON-SURGICAL ISOLATION GOWN |
| Product Code | OEA |
| Date Received | 2016-11-15 |
| Catalog Number | 69190 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH, INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-15 |