MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-09-26 for PRECEPT 66-2411 manufactured by Guangzhou Fortunique.
[101600]
Complaints of irritation at an in-serve evaluation. Primary skin irritation studies were performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 59995-1997-00001 |
| MDR Report Key | 124264 |
| Report Source | 07 |
| Date Received | 1997-09-26 |
| Date of Report | 1997-09-22 |
| Date of Event | 1996-10-24 |
| Date Mfgr Received | 1996-10-24 |
| Date Added to Maude | 1997-10-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECEPT |
| Generic Name | BOUFFANT CAP |
| Product Code | FYF |
| Date Received | 1997-09-26 |
| Model Number | 66-2411 |
| Catalog Number | 66-2411 |
| Lot Number | 960523 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 121667 |
| Manufacturer | GUANGZHOU FORTUNIQUE |
| Manufacturer Address | 3/F B. NO.18 TIAHEGAN XIANLIE ZHOUNG RD GUANGZHOU CH 510070 |
| Baseline Brand Name | PRECEPT |
| Baseline Generic Name | BOUFFANT CAP |
| Baseline Model No | 66-2411 |
| Baseline Catalog No | 66-2411 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-09-26 |