MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-01-10 for DERMA PRENE ISOTOUCH MICRO WHITE 20685980 manufactured by Ansell Lanka (pvt) Ltd..
[2563876]
Customer states that the employee is allergic to latex and used the derma prene isotouch white glove, however inside was a latex glove. The employee went into a 'anaphylactic shock' as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2012-00002 |
| MDR Report Key | 2413010 |
| Report Source | 04 |
| Date Received | 2012-01-10 |
| Date of Report | 2012-01-10 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2012-07-30 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TAMMY MCGRIFF |
| Manufacturer Street | 1635 INDUSTRIAL RD. |
| Manufacturer City | DOTHAN AL 36303 |
| Manufacturer Country | US |
| Manufacturer Postal | 36303 |
| Manufacturer Phone | 3347944231 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DERMA PRENE ISOTOUCH MICRO WHITE |
| Generic Name | SYNTHETIC SURGICAL GLOVE |
| Product Code | LZC |
| Date Received | 2012-01-10 |
| Catalog Number | 20685980 |
| Lot Number | 1106006605 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANSELL LANKA (PVT) LTD. |
| Manufacturer Address | EXPORT PROCESSING ZONE BIYAGAMA CE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-01-10 |