MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-21 for PURE GRIP GLOVE PF LATEX 1032507 manufactured by Adventa Health Sdn Bhd.
[17098556]
The customer alleges that a staff member, female, age unk, who has a known allergy (hypersensitivity) to latex, developed hives (urticaria) and her blood oxygen level fell very low. She did not wear the gloves around her. She was sent to the emergency room where they administered oxygen and benadryl. She was later released.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2011-00005 |
| MDR Report Key | 2387649 |
| Date Received | 2011-12-21 |
| Date of Report | 2011-11-22 |
| Date of Event | 2011-11-21 |
| Date Facility Aware | 2001-11-22 |
| Report Date | 2011-12-19 |
| Date Reported to FDA | 2011-12-19 |
| Date Reported to Mfgr | 2011-12-19 |
| Date Added to Maude | 2011-12-27 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 41 WEAVER RD. |
| Manufacturer City | DENVER PA 17517 |
| Manufacturer Country | US |
| Manufacturer Postal | 17517 |
| Manufacturer G1 | HENRY SCHEIN, INC. |
| Manufacturer Street | 41 WEAVER RD. |
| Manufacturer City | DENVER PA 17517 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17517 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PURE GRIP GLOVE PF LATEX |
| Generic Name | LATEX EXAMINATION GLOVE |
| Product Code | LYY |
| Date Received | 2011-12-21 |
| Returned To Mfg | 2011-11-30 |
| Catalog Number | 1032507 |
| Lot Number | 1004P535 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVENTA HEALTH SDN BHD |
| Manufacturer Address | KLUANG, MY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-21 |