MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-07-19 for BUBBLE GUM FLAVORED POWEDERED LATEX GLOVES - SM 21322 manufactured by Shield Gloves/sgmp/haiku/holdings.
[49851823]
Device was not returned to manufacturing site for an evaluation. Device discarded by user.
Patient Sequence No: 1, Text Type: N, H10
[49851824]
The mother of the patient called asking for the msds on the gloves that were used at their dental office. She reported this event after her child received a fluoride treatment. The child started to cough and vomit. She had an epi pen in her possession but did not use at the time of the incident. No additional medical treatment was sought. The child was doing well when the mother called. Allergies to latex have not been previously reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024980-2016-00002 |
| MDR Report Key | 5803648 |
| Report Source | OTHER |
| Date Received | 2016-07-19 |
| Date of Report | 2016-07-14 |
| Date of Event | 2016-06-15 |
| Date Added to Maude | 2016-07-19 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS ASMITA PATEL |
| Manufacturer Street | 2260 WENDT ST |
| Manufacturer City | ALGONQUIN IL 60102 |
| Manufacturer Country | US |
| Manufacturer Postal | 60102 |
| Manufacturer Phone | 8474565642 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUBBLE GUM FLAVORED POWEDERED LATEX GLOVES - SM |
| Generic Name | BUBBLE GUM FLAVORED POWEDERED LATEX GLOVES - SM |
| Product Code | LYY |
| Date Received | 2016-07-19 |
| Catalog Number | 21322 |
| Operator | DENTAL HYGIENIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHIELD GLOVES/SGMP/HAIKU/HOLDINGS |
| Manufacturer Address | 33 2ND FLOOR, JALAN SS 15/4C 47500 SUBANG JAYA SELANGOR, DA MY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-19 |