MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-04 for BAXTER - CONVERTORS * 3274 manufactured by Baxter - Convertors/hospital Supply Division.
[70940]
Mri showed metal artifact pt questioned, denyed any metal, bb, etc. When finished broken sewing machine needle found woven in "comfort bouffant cap" elastic band. Significant hazard potential.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 117747 |
| MDR Report Key | 117747 |
| Date Received | 1997-09-04 |
| Date of Report | 1997-06-13 |
| Date of Event | 1997-06-11 |
| Date Added to Maude | 1997-09-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAXTER - CONVERTORS |
| Generic Name | COMFORT BOUFFANT CAP |
| Product Code | FYF |
| Date Received | 1997-09-04 |
| Returned To Mfg | 1997-06-13 |
| Model Number | * |
| Catalog Number | 3274 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 115482 |
| Manufacturer | BAXTER - CONVERTORS/HOSPITAL SUPPLY DIVISION |
| Manufacturer Address | 82 INVERNESS DR. ENGLEWOOD CO 80112 US |
| Baseline Brand Name | CAP, BOUFFANT, SPUNDBONDED, BLUE |
| Baseline Generic Name | BOUFFANT CAP |
| Baseline Model No | 3274 |
| Baseline Catalog No | 3274 |
| Baseline ID | NA |
| Baseline Device Family | APPAREL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K800511 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-09-04 |