MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for PROTEXIS PI BLUE WITH NEU-THERA SURGICAL GLOVES WITH EMOLLIENT COATING. REF NUMBER 2D73EB75 manufactured by Cardinal Health 200 Llc.
[143260081]
A dead lizard found in packaging of sterile glove prior to patient's surgery. Pulled all gloves with matching lot numbers. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086162 |
| MDR Report Key | 8550619 |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-04-18 |
| Date Added to Maude | 2019-04-25 |
| 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 | PROTEXIS PI BLUE WITH NEU-THERA SURGICAL GLOVES WITH EMOLLIENT COATING. |
| Generic Name | SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2019-04-23 |
| Model Number | REF NUMBER 2D73EB75 |
| Lot Number | TSI8050363 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200 LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-23 |