MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2011-03-08 for GLOVE INSTAGARD PF SYN EXAM (VINYL) SZ S 8886I manufactured by .
[1917795]
Additional information learned - the employee's age and weight, and that her job title is (b)(6). She has not had allergies, or allergy testing in the past.
Patient Sequence No: 1, Text Type: D, B5
[1935399]
Female employee's hands were red/inflamed like a first degree burn, with excoriation close to the wrists and base of her palms. Originally it was thought that this was due to the alcohol hand sanitizer being used, she now believes it is the glove. She was sent home from work and it is believed she was given prescriptive medication. She is using a different glove now without problems.
Patient Sequence No: 1, Text Type: D, B5
[8954704]
Complaint and sample forwarded to the manufacturing facility for investigation. Follow up report will be filed when results of investigation are completed.
Patient Sequence No: 1, Text Type: N, H10
[9083068]
Cardinal health has filed the initial medwatch and is filing this follow up report as the importer. The sample was received and evaluated. The device history record was reviewed, and no abnormalities were noted. Historical trending was done. A stimulation test was done with the returned sample, and the results were that no one developed an allergic phenomenon. A small percentage of the population may experience an allergic reaction to some of the anti-oxidants and accelerators which may be added during the manufacturing process. Some reactions may be caused by contact dermatitis, and may not be allergic in nature. The supplier has been appraised of this reported incident for close monitoring of the manufacturing process. We will continue to monitor for complaints of this nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2011-00010 |
| MDR Report Key | 2010349 |
| Report Source | 04,07 |
| Date Received | 2011-03-08 |
| Date of Report | 2011-03-29 |
| Date of Event | 2011-02-07 |
| Date Facility Aware | 2011-02-07 |
| Date Mfgr Received | 2011-02-07 |
| Device Manufacturer Date | 2010-07-01 |
| Date Added to Maude | 2012-05-24 |
| 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 | 0 |
| 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 | GLOVE INSTAGARD PF SYN EXAM (VINYL) SZ S |
| Generic Name | VINYL PATIENT EXAM GLOVE |
| Product Code | LYZ |
| Date Received | 2011-03-08 |
| Returned To Mfg | 2011-03-07 |
| Catalog Number | 8886I |
| Lot Number | 1T10J011 |
| Device Expiration Date | 2013-06-01 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-08 |