MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-05-31 for CUR4045R manufactured by Medline Industries Inc..
[109709064]
It was reported that the end-user experienced a reaction of hives, tongue and facial swelling, and redness to her face after using the gloves for approximately 20-30 minutes. The end-user states that she felt as though her "throat was closing. " reportedly, the end-user went to a hospital emergency department (ed) where she received an unidentified "steroid shot," famotidine, and benadryl. No diagnostic testing reported. She was not admitted to the hospital after her ed visit. The end-user reported that she has been taking benadryl every 4 hours since her ed visit. The box of gloves was reportedly discarded. There is no sample available to be returned to the manufacturer for evaluation. No additional product information provided. Since her ed visit, approximately 1 week ago, the end-user reports improvement of reported symptoms. Due to the reported incident, the need for medical intervention, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[109709065]
It was reported that the end-user experienced a reaction of hives, tongue and facial swelling, and redness to her face after using the gloves for approximately 20-30 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00049 |
| MDR Report Key | 7558152 |
| Report Source | CONSUMER |
| Date Received | 2018-05-31 |
| Date of Report | 2018-05-31 |
| Date of Event | 2018-05-25 |
| Date Mfgr Received | 2018-05-29 |
| Date Added to Maude | 2018-05-31 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | GLOVE,EXAM,NITRILE,PF,LF,40CT,OSFM |
| Product Code | LZA |
| Date Received | 2018-05-31 |
| Catalog Number | CUR4045R |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-05-31 |