MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-02-27 for ESTEEM STRETCHY SYNTH CREAM M 8882B manufactured by Cardinal Health.
[4199664]
Three nurses between the ages of 25-35 developed skin irritation and were seen by the infection nurse. They were given a cream (name not provided) and different gloves were bought for them. One of the three also went to a clinic, but there is no additional information about treatment.
Patient Sequence No: 1, Text Type: D, B5
[11623306]
Cardinal health is filing this as the importer. The complaint was forwarded to the manufacturing facility for investigation. We are awaiting sample return from the customer. When samples are received they will be forwarded to the manufacturing facility for investigation. A follow up report will be filed when the results of investigation are completed.
Patient Sequence No: 1, Text Type: N, H10
[22525454]
Samples were received and the lot# was provided. The device history record was reviewed and no abnormalities were noted. Historical trending was done. Based on the returned samples, there was no skin irritation with the wearing test. There has been no change in the formulation of the glove. The supplier has been apprised of this reported incident for close monitoring of the manufacturing process. No corrective action will be taken at this time as we are unable to identify the root cause. We will continue to monitor complaints for any trends of this nature.
Patient Sequence No: 1, Text Type: N, H10
[22525455]
The customer has provided additional information since the initial medwatch was submitted. Apparently two of the three nurses did not require "cream" as initially reported. The 3rd nurse apparently started with a rash to both hands on (b)(6) 2013 and used non-medicated body cream. However she had symptoms reoccur in (b)(6) 2013 and was treated at a clinic with solumedrol 125mg im, and prednisone 20mg tabs. She is doing better now. This reaction was initially reported to cardinal health as occurring on 1/30/2014. The additional specifics of the reaction were not reported to cardinal health until 02/28/2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2014-00007 |
| MDR Report Key | 3649623 |
| Report Source | 04,07 |
| Date Received | 2014-02-27 |
| Date of Report | 2014-03-27 |
| Date of Event | 2014-01-30 |
| Date Facility Aware | 2014-01-30 |
| Report Date | 2014-02-14 |
| Date Reported to Mfgr | 2014-02-14 |
| Date Mfgr Received | 2014-01-30 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-02-27 |
| 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 | 0 |
| 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 | ESTEEM STRETCHY SYNTH CREAM M |
| Generic Name | GLOVE, PATIENT EXAMINATION, VINYL |
| Product Code | LYZ |
| Date Received | 2014-02-27 |
| Returned To Mfg | 2014-03-04 |
| Catalog Number | 8882B |
| Lot Number | 9R13P046 |
| Device Expiration Date | 2016-10-31 |
| Operator | NURSE |
| Device Availability | R |
| 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 | 2014-02-27 |