MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-12-28 for GLOVE, EXAM, NOVAPLUS PF STRETCH V484311 manufactured by Medline Industries, Inc..
[1777588]
Report that the glove leaked, resulting in exposure incident.
Patient Sequence No: 1, Text Type: D, B5
[8945077]
The gloves were being used during a dental procedure. Initially, it was reported that the gloves leaked and today, it was reported that an exposure incident occurred. The provider noticed blood on the inside of the glove and on her hand. She did not have any cuts or skin integrity issues of her hand. They inspected the glove and could not find where the blood had seeped in. The reporter stated that it is their policy to obtain post exposure f/u due to the fact that a large portion of their pt population is (b)(6). The individual reporting the incident to us could not confirm the provider sought (b)(6) post exposure treatment but assumes she did. The actual sample was not returned for evaluation. Two unopened boxes and one partial box of 8 gloves were returned for evaluation. Gloves from each of the boxes were water tested. Twenty gloves from the two unopened boxes and all 8 gloves from the partial box were tested and the issue could be not be confirmed. No leak or integrity issues were identified. The sample was not returned for evaluation. Due to the report that (b)(6) post exposure treatment was sought, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2010-00080 |
| MDR Report Key | 1949213 |
| Report Source | 06 |
| Date Received | 2010-12-28 |
| Date of Report | 2010-12-29 |
| Date of Event | 2010-11-15 |
| Date Facility Aware | 2010-11-16 |
| Date Mfgr Received | 2010-11-16 |
| Date Added to Maude | 2012-03-14 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | MEDLINE INDUSTRIES, INC. |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLOVE, EXAM, NOVAPLUS PF STRETCH |
| Generic Name | NONE |
| Product Code | LYY |
| Date Received | 2010-12-28 |
| Model Number | V484311 |
| Lot Number | MF004610255 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2010-12-28 |