MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-09-06 for GLV EXAM ESTEEM SYN PF(VYL) MD 8882 manufactured by .
[2171883]
Over last several months, nurse has had a rash/itching/redness and fluid filled blisters at times on both hands around her knuckles. She is in gloves for ten hours at a times in long cases. Hands itch/tingle. The surgical scrub she uses may also be a factor. She saw a dermatologist, and then an allergist who performed scratch testing which apparently showed an allergy to 4 things. Dermatologist prescribed steroid cream.
Patient Sequence No: 1, Text Type: D, B5
[9513680]
Cardinal health is filing this as the importer. The customer did not provide the sample, however they did provide the lot number. The device history record was reviewed and no abnormalities were noted. Historical trending was done. The potential root cause could not be identified. However, a small percentage of the population may experience an allergy to some of the chemicals which may be added during the manufacturing process. Some reactions may be caused by contact dermatitis and may not be allergic in nature at all. The supplier was apprised of the complaint and will closely monitor the manufacturing process. We will continue to monitor for complaints of this nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2011-00070 |
| MDR Report Key | 2235371 |
| Report Source | 05,07 |
| Date Received | 2011-09-06 |
| Date of Report | 2011-09-06 |
| Date of Event | 2011-06-01 |
| Date Facility Aware | 2011-08-12 |
| Date Mfgr Received | 2011-08-12 |
| Device Manufacturer Date | 2011-05-01 |
| Date Added to Maude | 2011-09-06 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CARDINAL HEALTH 200, LLC |
| Manufacturer Street | 1430 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLV EXAM ESTEEM SYN PF(VYL) MD |
| Generic Name | GLOVE, PATIENT, EXAMINATION, VINYL |
| Product Code | LYZ |
| Date Received | 2011-09-06 |
| Catalog Number | 8882 |
| Lot Number | 1N11EO39 |
| Device Expiration Date | 2014-04-30 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-06 |