MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-13 for GLOVE SURGICAL PROTEXIS PI MICRO 2D73PM60 manufactured by Cardinal Health (thailand) 222 Limited.
[144872923]
The lot number was not provided; therefore, the device history record could not be reviewed. Since the complaint sample was not available for evaluation an exact root cause could not be determined, however the healthcare assistant did test positive for an allergy to accelerators. Per historical testing, this glove passed the requirements of the primary skin irritation test per the technical service report. The protexis pi micro gloves have passed a series of tests prescribed by regulatory agencies for the intended use. However, the possibility of an individual experiencing reactions to certain chemicals used during the manufacturing process cannot be ruled out. Although no trends for this issue were noted during the last twelve months, we will continue to monitor complaints for any unfavorable trends.
Patient Sequence No: 1, Text Type: N, H10
[144872924]
Healthcare assistant initially developed irritation on backs of hands, followed by blistering of fingers and palms of hands. Hands and finger tips developed deep cracks, and irritation spread along forearms; he also had significant pain. He was seen initially by a gp and prescribed steroid creams. He was also seen by occupational health and referred for a dermatology consultation and skin tests which showed an allergy to carbamix and an accelerator. Six weeks were required to heal. He currently needs to wear cotton gloves under all gloves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00317 |
| MDR Report Key | 8604862 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-13 |
| Date of Report | 2019-05-13 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2019-05-13 |
| 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 Phone | 8478874151 |
| Manufacturer G1 | CARDINAL HEALTH (THAILAND) 222 LIMITED |
| Manufacturer Street | 7/111 MOO 4 HIGHWAY #331, MABY |
| Manufacturer City | RAYONG 21140 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 21140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLOVE SURGICAL PROTEXIS PI MICRO |
| Generic Name | SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2019-05-13 |
| Catalog Number | 2D73PM60 |
| Lot Number | UNKOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH (THAILAND) 222 LIMITED |
| Manufacturer Address | 7/111 MOO 4 HIGHWAY #331, MABY RAYONG 21140 TH 21140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-13 |