MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-30 for GAMMEX 20685765 manufactured by Ansell Healthcare Products Llc.
[56024743]
Patient Sequence No: 1, Text Type: N, H10
[56024744]
A foreign object was found in the finger of a sterile glove opened in the outpatient clinic. The foreign object resembled a yellow wood chip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5989863 |
| MDR Report Key | 5989863 |
| Date Received | 2016-09-30 |
| Date of Report | 2016-08-29 |
| Date of Event | 2016-08-09 |
| Report Date | 2016-08-29 |
| Date Reported to FDA | 2016-08-29 |
| Date Reported to Mfgr | 2016-08-29 |
| Date Added to Maude | 2016-09-30 |
| 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 | GAMMEX |
| Generic Name | NON-LATEX POLYISOPRENE SURGICAL GLOVES |
| Product Code | LZA |
| Date Received | 2016-09-30 |
| Returned To Mfg | 2016-08-10 |
| Catalog Number | 20685765 |
| Lot Number | 1602432904 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANSELL HEALTHCARE PRODUCTS LLC |
| Manufacturer Address | 1635 INDUSTRIAL ROAD DOTHAN AL 36303 US 36303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-30 |