MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-02-06 for ESTEEM STRETCHY SYNTH EXAM GLOVE 8882B manufactured by Cardinal Health.
[2515508]
A rehabilitation nursing technician began to open a box of gloves by pulling open the perforated tab on the top of the box and was "scratched" by an object inside the box. When the box was fully opened a "wrapped blade" was inside the box at the very top under the perforated tab. It appeared to be similar to a box cutter blade, wrapped in heavy paper and then wrapped again with heavy tape. The employee's skin was broken slightly but did not bleed. She received medical attention and testing that her employer does when there is exposure to body fluids, including a tetanus injection.
Patient Sequence No: 1, Text Type: D, B5
[9617460]
(b)(4). The device history record was reviewed and no abnormalities were noted. Historical trending was done. An investigation was initiated per the received photo. The wrapped blade is used by the employee to cut off the sealing tape to the shipping case. One of the employees accidentally dropped the blade into the box while packing. The manufacturer/supplier, (b)(4), was apprised of this complaint for close monitoring during the packing process. Actions to be taken are: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2012-00004 |
| MDR Report Key | 2439343 |
| Report Source | 05,07 |
| Date Received | 2012-02-06 |
| Date of Report | 2012-02-06 |
| Date of Event | 2012-01-07 |
| Date Facility Aware | 2012-01-09 |
| Report Date | 2012-02-06 |
| Date Reported to FDA | 2012-02-06 |
| Date Reported to Mfgr | 2012-01-09 |
| Date Mfgr Received | 2012-01-09 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2012-02-06 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 EXAM GLOVE |
| Generic Name | VINYL PATIENT EXAMINATION GLOVE |
| Product Code | LYZ |
| Date Received | 2012-02-06 |
| Returned To Mfg | 2012-01-11 |
| Catalog Number | 8882B |
| Lot Number | 6Y11N023 |
| Device Expiration Date | 2014-09-30 |
| Device Availability | R |
| 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 | 2012-02-06 |