MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-04-05 for GLV EXAM PF THIN NITRILE FINGER TEX LG 88TN04L manufactured by Cardinal Health Malaysia 211 Sdn.bhd.
[104449363]
The complaint was forwarded to the manufacturing facility for investigation. A follow up report will be filed once their investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[104449366]
Housekeeper reports that the gloves have caused her hands to break out. The palms of her hands have turned yellow, her knuckles and fingers have turned darker and she has cuts on her hands as well as sores in between her fingers and at the knuckles. She saw a dermatologist and a physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2018-00174 |
| MDR Report Key | 7399288 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-04-05 |
| Date of Report | 2018-04-27 |
| Date of Event | 2018-02-26 |
| Date Mfgr Received | 2018-03-07 |
| Device Manufacturer Date | 2017-08-01 |
| Date Added to Maude | 2018-04-05 |
| 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 | PATRICIA TUCKER |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer G1 | CARDINAL HEALTH MALAYSIA 211 SDN.BHD |
| Manufacturer Street | ZONE PHASE IV, MK 12 LINTANG , |
| Manufacturer City | BAYAN LEPAS 11900 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 11900 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLV EXAM PF THIN NITRILE FINGER TEX LG |
| Generic Name | POLYMER PATIENT EXAMINATION GLOVE |
| Product Code | LZA |
| Date Received | 2018-04-05 |
| Catalog Number | 88TN04L |
| Lot Number | 11H17K007 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH MALAYSIA 211 SDN.BHD |
| Manufacturer Address | ZONE PHASE IV, MK 12 LINTANG , BAYAN LEPAS 11900 MY 11900 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-05 |