MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1998-05-12 for MICRO-TOUCH LATEX MEDICAL GLOVES UNK manufactured by Johnson & Johnson Medical, Mfg, Sdn.bhd.
[132679]
A registered nurse reported that she developed an allergy to latex. She states that she wore latex gloves made by various glove mfrs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1618732-1998-00116 |
| MDR Report Key | 167030 |
| Report Source | 00 |
| Date Received | 1998-05-12 |
| Date of Report | 1998-04-15 |
| Date Mfgr Received | 1998-04-15 |
| Date Added to Maude | 1998-05-13 |
| 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 | 0 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICRO-TOUCH LATEX MEDICAL GLOVES |
| Generic Name | GLOVES, MEDICAL, LATEX |
| Product Code | LYX |
| Date Received | 1998-05-12 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 162532 |
| Manufacturer | JOHNSON & JOHNSON MEDICAL, MFG, SDN.BHD |
| Manufacturer Address | LOT 16, PERSIARAN PERUSAHAAN SECTION 23, SHAH ALAM SELANGOR DARUL EHSAN MY 40000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-05-12 |