MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2017-08-29 for STERLING SG NITRILE SENSI-GUARD POWER-FREE EXAM GLOVES 41660 104166000 manufactured by Halyard Health.
[83876615]
The actual complaint product 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. All information reasonably known as of (b)(6) 2017 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. This product incident is documented in the halyard health complaint database and identified as complaint (b)(4). Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[83876616]
It was reported that a customer alleged having an allergic reaction from wearing gloves that involved difficulty breathing, numbness and tingling of the lips. Per the customer the gloves were worn for five minutes prior to having a reaction. Benadryl was taken for the symptoms that lasted for 45 minutes after the gloves were taken off. The customer? S hands were itchy but no rash, hives or medical intervention reported. The customer is reported to be in stable condition. The customer is allergic to penicillin and fish. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2017-00006 |
| MDR Report Key | 6827209 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-08-29 |
| Date of Report | 2017-08-03 |
| Date Mfgr Received | 2017-08-03 |
| Date Added to Maude | 2017-08-29 |
| 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 | STERLING SG NITRILE SENSI-GUARD POWER-FREE EXAM GLOVES |
| Generic Name | STERLING NITRILE EXAM GLOVES |
| Product Code | LZA |
| Date Received | 2017-08-29 |
| Model Number | 41660 |
| Catalog Number | 104166000 |
| Lot Number | UNKNOWN |
| Operator | NURSE |
| 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 | 2017-08-29 |