MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-09-04 for CAP, BOUFFANT, SPUNBONDED, BLUE 3274 manufactured by Allegiance Healthcare.
[18438753]
During an mri the physician and staff in mri were baffled as to why the images were showing distorted, as though a metal were present. When the exam was completed the nurse found a sewing needle in the bouffant cap on the pt. She found it by sticking herself. Pt had to undergo another mri and more importantly, had this needle come loose from the cap due to the magnetic pull of the scanner, it would have moved freely about the chamber at a high rate of speed, potentially imbedding herself into the pt, or when the nurse brought the pt out of the scanner, the needle could have been shot across the room at a high rate of speed injuring anyone in its path.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-1997-00172 |
| MDR Report Key | 117750 |
| Report Source | 05,06 |
| Date Received | 1997-09-04 |
| Date of Event | 1997-06-11 |
| Date Reported to Mfgr | 1997-06-13 |
| Date Mfgr Received | 1997-06-26 |
| Date Added to Maude | 1997-09-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAP, BOUFFANT, SPUNBONDED, BLUE |
| Generic Name | BOUFFANT CAP |
| Product Code | FYF |
| Date Received | 1997-09-04 |
| Returned To Mfg | 1997-06-13 |
| Model Number | 3274 |
| Catalog Number | 3274 |
| Lot Number | 97CA07611 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 115482 |
| Manufacturer | ALLEGIANCE HEALTHCARE |
| Manufacturer Address | 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 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 | 1997-09-04 |