MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-02-02 for POWDERFREE NITRILE TEXTURED GLOVE M 50 50602 991050602 manufactured by Halyard Health.
[66433184]
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. 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
[66433185]
It was reported that a patient had an allergic reaction to the nitrile gloves and experienced shortness of breath. Additional information received on 17-jan-2017 that stated, "a nurse used gloves to deliver mitomycin chemo drug to the physician. The nurse only delivered the chemo drug, nothing else. Shortly after putting gloves on the nurse noticed a burning on/around the fingers that quickly spread to the nurses arms in the form of a rash. It was the first time the nurse used these gloves. The nurse was taken to the emergency room with shortness of breath, and was nearly/but not intubated. " no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[68989472]
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 (b)(4). This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3011270181-2017-00001 |
| MDR Report Key | 6298620 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-02-02 |
| Date of Report | 2017-02-08 |
| Date of Event | 2017-01-13 |
| Date Mfgr Received | 2017-02-08 |
| Date Added to Maude | 2017-02-02 |
| 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 | SAFESKIN MEDICAL & SCIENTIFIC (THAILAND), LTD. |
| Manufacturer Street | 200 MOO 8 KANCHANAVANICH ROAD TAMBOL PRIK |
| Manufacturer City | SADAO SONGKHLA GA 90120 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 90120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWDERFREE NITRILE TEXTURED GLOVE M 50 |
| Generic Name | EXAM GLOVES NITRILE |
| Product Code | LZC |
| Date Received | 2017-02-02 |
| Model Number | 50602 |
| Catalog Number | 991050602 |
| Lot Number | UNKNOWN |
| Operator | NURSE |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-02-02 |