MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-07-19 for CHERRY FLAVORED POWDER-FREE LATEX GLOVES X-S 21362 manufactured by Shield Gloves/sgmp/haiku.
[49851628]
Device was discarded by the user, unable to follow up.
Patient Sequence No: 1, Text Type: N, H10
[49851630]
A patient's father called requesting the msds for the cherry flavored powder-free latex gloves. The latex gloves were used during the treatment of the patient. The next day the child displayed welts on her face, swollen hands and eyes. Medical treatment was sought for symptoms which were classified as a latex allergic reaction. The patient's father reports that the child has recovered from the symptoms.
Patient Sequence No: 1, Text Type: D, B5
[54551499]
An incorrect catalog number was provided in the original submission (2024980-2016-00001). The catalog number 22501 should be catalog number 21362.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024980-2016-00001 |
| MDR Report Key | 5802989 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-07-19 |
| Date of Report | 2016-08-10 |
| Date of Event | 2016-06-16 |
| Date Mfgr Received | 2016-06-16 |
| 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 |
| 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 |
| Manufacturer G1 | YOUNG INNOVATIONS LLC DBA PLAK SMACKER |
| Manufacturer Street | 2260 WENDT ST |
| Manufacturer City | ALGONQUIN IL 60102 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60102 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHERRY FLAVORED POWDER-FREE LATEX GLOVES X-S |
| Generic Name | CHERRY FLAVORED POWDER-FREE LATEX GLOVES X-S |
| Product Code | LYY |
| Date Received | 2016-07-19 |
| Catalog Number | 21362 |
| Operator | DENTAL HYGIENIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHIELD GLOVES/SGMP/HAIKU |
| Manufacturer Address | HOLDINGS, 33, 2ND FLOOR, JALAN 47500 SUBANG JAYA-SELANGOR DARUL, MALAYSIA, US MY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-19 |