MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-08-30 for POWDER-FREE LATEX EXAM GLOVE 88PL04L manufactured by Cardinal Health.
[1372746]
On (b)(6) 2010, the customer reported to cardinal health that three nurses had irritation issues with the glove. Rn developed a reaction on her hands, and dry/burning nares. It is known that she sought medical care but it is not known what treatment was given.
Patient Sequence No: 1, Text Type: D, B5
[8750904]
The customer was not able to identify the lot number, therefore, the device history record could not be reviewed. Historical trending was done. The customer was not able to provide the sample, therefore, the root cause could not be identified. A small percentage of the population may experience allergic reactions to some of the anti-oxidants and accelerators which may be added during the mfg process. Often reactions may be caused by contact dermatitis and may not be allergic in nature at all. We will continue to monitor complaints for any trends.
Patient Sequence No: 1, Text Type: N, H10
[6318780]
On (b)(6) 2010 the customer reported to cardinal health that three nurses had irritation issues with the glove. Rn developed rash/breaks in skin/pain/itching. She sought medical care and was given hydrocortisone cream.
Patient Sequence No: 2, Text Type: D, B5
[13518732]
The customer was not able to identify the lot number, therefore the device history record could not be reviewed. Historical trending was done. The customer was not able to provide the sample, therefore the root cause could not be identified. A small percentage of the population may experience allergic reactions to some of the anti-oxidants and accelerators which may be added during the mfg process. Often reactions may be caused by contact dermatitis and may not be allergic in nature at all. We will continue to monitor complaints for any trends.
Patient Sequence No: 2, Text Type: N, H10
[6318814]
On (b)(6) 2010 the customer reported to cardinal health that three nurses had irritation issues with the glove. Rn developed a red, bumpy, itchy and painful rash. She sought medical care and was given clobex lotion.
Patient Sequence No: 3, Text Type: D, B5
[14313655]
The customer was not able to identify the lot number, therefore the device history record could not be reviewed. Historical trending was done. The customer was not able to provide the sample, therefore the root cause could not be identified. A small percentage of the population may experience allergic reactions to some of the anti-oxidants and accelerators which may be added during the mfg process. Often reactions may be caused by contact dermatitis and may not be allergic in nature at all. We will continue to monitor complaints for any trends.
Patient Sequence No: 3, Text Type: N, H10
| Report Number | 1423507-2010-00038 |
| MDR Report Key | 1833060 |
| Report Source | 05,07 |
| Date Received | 2010-08-30 |
| Date of Report | 2010-08-26 |
| Date of Event | 2010-07-01 |
| Date Mfgr Received | 2010-08-05 |
| Date Added to Maude | 2011-04-21 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWDER-FREE LATEX EXAM GLOVE |
| Generic Name | LATEX PATIENT EXAMINATION GLOVE |
| Product Code | LYY |
| Date Received | 2010-08-30 |
| Catalog Number | 88PL04L |
| Lot Number | NO LOT GIVEN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-08-30 |
| 2 | 0 | 1. Other | 2010-08-30 |
| 3 | 0 | 1. Other | 2010-08-30 |