MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-12-20 for CUR8234 manufactured by Medline Industries, Inc..
[18502849]
It was reported that strikethrough occurred while wearing a glove and the end user sought post exposure treatment.
Patient Sequence No: 1, Text Type: D, B5
[18743334]
It was reported that the clinician was changing a bandage on a pt while wearing the gloves. Upon removal of the gloves, she found blood inside of one of the fingertips. No visible holes or tears were seen by the clinician. The pt was (b)(6) and the clinician received post exposure treatment. The sample was not returned for eval. Without a sample to evaluate, a root cause has not been determined. We have had no other similar issues reported for this device. The source of entry of the reported strikethrough is not known. No corrective action is indicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2011-00062 |
| MDR Report Key | 2389995 |
| Report Source | 06 |
| Date Received | 2011-12-20 |
| Date of Report | 2011-12-07 |
| Date of Event | 2011-11-10 |
| Date Mfgr Received | 2011-11-10 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2012-07-27 |
| 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 | 0 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | STRETCH VINYL EXAM GLOVE |
| Product Code | LYZ |
| Date Received | 2011-12-20 |
| Model Number | CUR8234 |
| Lot Number | MA105206181 |
| 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 | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-12-20 |