MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-08-28 for ESTEEM STRETCHY SYNTH CREAM M 8882B manufactured by Cardinal Health.
[3646394]
Nurse was checking on (b)(6) patient, and when she took the gloves off there was blood on her hand. She went to the emergency room for assessment and possible testing, and filed a report with infection prevention.
Patient Sequence No: 1, Text Type: D, B5
[10917342]
(b)(6) is filing this as the importer. The customer did not provide the sample, but did provide the lot number. Therefore, the device history record was reviewed and no abnormalities were note. Historical trending was done. Without the actual sample, it is difficult to assign a root cause. The probable cause of pinholes could be due to an isolated dirty or deteriorated former. The manufacturing team has been made aware of this complaint. They will take action to identify and remove the problematic formers, and replace them with new units. Additional lights were installed at the dipping line to carry out inspection of the formers. The teams will also closely monitor all manufacturing processes to ensure the gloves meet all the required astm's specification prior to release. We will continue to monitor for complaints of this nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2013-00035 |
| MDR Report Key | 3313365 |
| Report Source | 04,07 |
| Date Received | 2013-08-28 |
| Date of Report | 2013-08-28 |
| Date of Event | 2013-08-06 |
| Date Facility Aware | 2013-08-06 |
| Report Date | 2013-08-07 |
| Date Reported to Mfgr | 2013-08-07 |
| Date Mfgr Received | 2013-08-06 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2013-08-28 |
| 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 | 2013-08-28 |
| Catalog Number | 8882B |
| Lot Number | 9V13D014 |
| Device Expiration Date | 2016-03-31 |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | * |
| 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 | 2013-08-28 |