MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-12-14 for PRECEPT 66-2232 manufactured by Fortunique/ Guangzhou Fortunique, Ltd..
[206067]
Complaint of irritation at an in-serve eval. Primary skin irritation studies were performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018223-1999-00001 |
| MDR Report Key | 260532 |
| Report Source | 07 |
| Date Received | 1999-12-14 |
| Date of Report | 1999-12-07 |
| Date of Event | 1999-11-09 |
| Date Mfgr Received | 1999-11-09 |
| Date Added to Maude | 2000-02-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MALINDA GRAVES |
| Manufacturer Street | * |
| Manufacturer City | ARDEN NC 28704 |
| Manufacturer Country | US |
| Manufacturer Postal | 28704 |
| Manufacturer Phone | 8004526964 |
| Manufacturer G1 | FORTUNIQUE/ GUANGZHOU FORTUNIQUE, LTD. |
| Manufacturer Street | 3/FB. NO. 18 TIAHEGAN XIANLIE ZHONG ROAD |
| Manufacturer City | GUANGZHOU 510070 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 510070 |
| 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 | 1999-12-14 |
| Model Number | 66-2232 |
| Catalog Number | 66-2232 |
| Lot Number | 990321 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 252339 |
| Manufacturer | FORTUNIQUE/ GUANGZHOU FORTUNIQUE, LTD. |
| Manufacturer Address | 3/FB. NO. 18 TIAHEGAN XIANLIE ZHONG ROAD GUANGZHOU CH 510070 |
| Baseline Brand Name | PRECEPT |
| Baseline Generic Name | BOUFFANT CAP |
| Baseline Model No | 66-2232 |
| Baseline Catalog No | 66-2232 |
| Baseline ID | LOT # 990321 |
| Baseline Device Family | BOUFFANT CAPS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-12-14 |