MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-11 for * BS-0813-S manufactured by E. Benson Hood Laboratories, Inc..
[2701743]
Explant of bronchial stent. Patient who has history of end-stage lung disease due to pulmonary fibrosis who has undergone bilateral sequential pulmonary transplantation approximately 6 months ago. She has had postoperative gastroesophageal reflux and has had inflammatory stenosis of the bronchus intermedius ultimately requiring placement of a silastic stent, 8 x 13 millimeters. She had recent surveillance bronchoscopy, which indicated possible migration or distortion of the stent and repeat airway evaluation is recommended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2637552 |
| MDR Report Key | 2637552 |
| Date Received | 2012-06-11 |
| Date of Report | 2012-06-06 |
| Date of Event | 2012-05-07 |
| Report Date | 2012-06-06 |
| Date Reported to FDA | 2012-06-11 |
| Date Added to Maude | 2012-07-02 |
| 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 | * |
| Generic Name | STENT, BRONCHIAL |
| Product Code | FWN |
| Date Received | 2012-06-11 |
| Returned To Mfg | 2012-05-11 |
| Model Number | * |
| Catalog Number | BS-0813-S |
| Lot Number | 11021 |
| ID Number | * |
| Device Availability | R |
| Device Age | 4 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | E. BENSON HOOD LABORATORIES, INC. |
| Manufacturer Address | 575 WASHINGTON STREET PEMBROKE MA 02359 US 02359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-11 |