MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-07 for ESTEEM 8816NB manufactured by Cardinal Health.
[94408954]
New gloves repeatedly ripping when taken out of box and worn. Staff report several similar incidents related to this brand of glove. Ripped gloves are discarded. New gloves are utilized. No reports of patient or staff harm as a result of the weak gloves have been made. Specific patient not applicable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073845 |
| MDR Report Key | 7100903 |
| Date Received | 2017-12-07 |
| Date of Report | 2017-12-06 |
| Date of Event | 2017-12-05 |
| Date Added to Maude | 2017-12-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | ESTEEM |
| Generic Name | STRETCHY NITRILE GLOVES |
| Product Code | LZC |
| Date Received | 2017-12-07 |
| Catalog Number | 8816NB |
| Lot Number | 7F17D508 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-07 |