MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,user facility report with the FDA on 2017-10-03 for PURPLE NITRILE* EXAM GLOVE 55082 991055082 manufactured by Halyard Health.
[88113224]
The actual glove involved in the complaint was not returned for evaluation. A review of the device history record is not possible as no lot number was provided. Root cause could not be determined. Images provided of the skin graft show that the injury appears to be above the skin area the glove normally covers. Additionally, the glove is not intended to provide a thermal barrier. All information reasonably known as of 02oct2017 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by halyard health represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health. Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[88113225]
It was reported that a customer was pouring boiling nitric acid into a beaker and without warning a chemical reaction occurred causing acid to spill onto the wrist. The boiling acid burned through the purple nitrile gloves causing third-degree burns, which required a skin graft using skin from the customer? S right leg. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2017-00007 |
| MDR Report Key | 6912413 |
| Report Source | CONSUMER,USER FACILITY |
| Date Received | 2017-10-03 |
| Date of Report | 2017-09-14 |
| Date of Event | 2016-02-19 |
| Date Mfgr Received | 2017-09-14 |
| Date Added to Maude | 2017-10-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | HALYARD HEALTH INC. |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PURPLE NITRILE* EXAM GLOVE |
| Generic Name | EXAM GLOVES NITRILE |
| Product Code | LZC |
| Date Received | 2017-10-03 |
| Model Number | 55082 |
| Catalog Number | 991055082 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-03 |