MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-18 for (3) THYROID SHIELDS NI manufactured by Burlington Medical Supplies, Inc..
[19776736]
Three thyroid shields purchased early 1997. Tested on 7-14-97 and found to be contaminated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011730 |
| MDR Report Key | 106314 |
| Date Received | 1997-07-18 |
| Date of Report | 1997-07-18 |
| Date of Event | 1997-07-14 |
| Date Added to Maude | 1997-07-21 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | (3) THYROID SHIELDS |
| Generic Name | THYROID SHIELD |
| Product Code | KPY |
| Date Received | 1997-07-18 |
| Returned To Mfg | 1997-07-15 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 104533 |
| Manufacturer | BURLINGTON MEDICAL SUPPLIES, INC. |
| Manufacturer Address | 32 STEVENS ST. P.O. BOX 1388 HAVERHILL MA 01830 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-07-18 |