MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for FG2602 manufactured by Medline Industries Inc..
[140003125]
It was reported that end-user sustained a cut to the tip of her left thumb while donning the nitrile exam glove. No further details were provided regarding the description of the injury. Per report, after glove was taken off, a "glass" remained in end user's thumb and upon inspection of the glove, it was noticed that there was a "black ring on the tip of the thumb area. " it was reported that immediately after the incident occurred, a staff member helped remove the retained glass through an unidentified method and end user's wound was washed with soap and water. No further tests or treatment was required. The end-user is reportedly doing fine at this time. The reported incident did not impact a patient. Due to the reported event and required medical intervention to retrieve the retained glass from end user's thumb, this medwatch is being filed. The sample is not available to be returned for evaluation. A definitive root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[140003126]
It was reported that a nurse sustained a cut to the tip of her left thumb while donning the nitrile exam glove, which reportedly had a foreign particulate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00039 |
| MDR Report Key | 8451314 |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-02-26 |
| Date Mfgr Received | 2019-02-27 |
| Date Added to Maude | 2019-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | GLOVE,EXAM,NITRL,PF,SELECT,TXT FNGR,M |
| Product Code | LZA |
| Date Received | 2019-03-26 |
| Catalog Number | FG2602 |
| Lot Number | EG810557785 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-26 |