MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-13 for PROTEXIS 2D72PT65X manufactured by Cardinal Health 200, Llc.
[174708160]
Two instances of holes in sterile gloves. Both times have been in the 6. 5 size. This is not being caused by the person putting on the gloves, rather the holes are there when we don sterile garb. One glove that had a hole was saved. The hole was in the tip of the right hand middle finger. I do have a picture. In the picture, we put a black circle around the hole, which is about the size of a straight pin head. No patient was involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9580601 |
| MDR Report Key | 9580601 |
| Date Received | 2020-01-13 |
| Date of Report | 2019-11-06 |
| Date of Event | 2019-10-29 |
| Report Date | 2019-11-06 |
| Date Reported to FDA | 2019-11-06 |
| Date Reported to Mfgr | 2020-01-13 |
| Date Added to Maude | 2020-01-13 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | PROTEXIS |
| Generic Name | SURGEONS GLOVES |
| Product Code | KGO |
| Date Received | 2020-01-13 |
| Model Number | 2D72PT65X |
| Catalog Number | 2D72PT65X |
| Lot Number | TS19050227 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-13 |