MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-06-16 for ILLUSION GLOVE PF LATEX GRAPE 1032711 manufactured by Purnabia Adventa Health.
[2094381]
The customer alleges that a staff member, female, (b)(6), who has a known allergy (hypersensitivity) to latex, developed swelling of the throat, and difficulty breathing (dyspnea). She did not wear the gloves but other staff members were wearing these gloves around her. She took a benadryl before going to the hospital. The hospital did administer a medication but not through an iv. She was monitored and released.
Patient Sequence No: 1, Text Type: D, B5
[9189219]
Additional catalog #: 1032712. Additional lot #: 1010348.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2411236-2011-00002 |
| MDR Report Key | 2153078 |
| Report Source | 99 |
| Date Received | 2011-06-16 |
| Date of Report | 2011-05-19 |
| Date of Event | 2011-05-19 |
| Date Facility Aware | 2011-05-19 |
| Report Date | 2011-06-16 |
| Date Reported to FDA | 2011-06-16 |
| Date Reported to Mfgr | 2011-06-16 |
| Date Added to Maude | 2011-11-02 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ILLUSION GLOVE PF LATEX GRAPE |
| Generic Name | LATEX EXAMINATION GLOVE GRAPE |
| Product Code | LYY |
| Date Received | 2011-06-16 |
| Returned To Mfg | 2011-06-06 |
| Catalog Number | 1032711 |
| Lot Number | 1010349 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PURNABIA ADVENTA HEALTH |
| Manufacturer Address | KLUANG MY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-06-16 |