MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-01-12 for CYPRESS TRILON 2000 PF VINYL EXAM GLOVE 25-970 manufactured by Zibo Hengchang Plastic And Rubber Products Co. Ltd.
[5414324]
On (b)(6) 2014, (b)(6) called from (b)(6) claiming that an individual went into anaphylactic shock after donning the vinyl glove and received 0. 3 epipen. The individual went to the er where she also received 50 mgs of benadryl and 2 steroid shots. Ms (b)(6) stated the individual is doing better after 6 days of oral steroids. Further follow up was conducted by qa with ms (b)(6) on (b)(6) 2014, who stated the individual had the vinyl gloves on for 3 seconds, felt a burning sensation, immediately removed the gloves and washed her hands. Ms (b)(6) stated the only known sensitivity the individual has is to latex. The vinyl gloves are not made with natural rubber latex. As of (b)(6) 2015, this is the only complaint registered for this item number and lot number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1451040-2015-00001 |
| MDR Report Key | 4417989 |
| Report Source | 99 |
| Date Received | 2015-01-12 |
| Date of Report | 2014-12-19 |
| Date of Event | 2014-12-13 |
| Date Facility Aware | 2014-12-19 |
| Report Date | 2015-01-08 |
| Date Added to Maude | 2015-01-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1202 SOUTH ROUTE 31 |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal | 60050 |
| Manufacturer G1 | CYPRESS MEDICAL PRODUCTS LLC |
| Manufacturer Street | 1202 SOUTH ROUTE 31 |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60050 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYPRESS TRILON 2000 PF VINYL EXAM GLOVE |
| Generic Name | VINYL PATIENT EXAM GLOVES |
| Product Code | LYZ |
| Date Received | 2015-01-12 |
| Catalog Number | 25-970 |
| Lot Number | CHD06-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIBO HENGCHANG PLASTIC AND RUBBER PRODUCTS CO. LTD |
| Manufacturer Address | ZIBO CITY, SHANGDONG CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2015-01-12 |