MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-10-17 for BLTPRT PLUS 5MM-12MM TRC W/BLTGRP 179075P manufactured by Covidien.
[5097999]
Procedure: colectomy. According to the reporter: a piece of seal broke off and was sitting on liver bed. Piece was retrieved. Current patient status: ok
Patient Sequence No: 1, Text Type: D, B5
[12419369]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[16018269]
(b)(4). Follow up report sent to fda on 03/17/2015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2014-00361 |
| MDR Report Key | 4180830 |
| Report Source | 06 |
| Date Received | 2014-10-17 |
| Date of Report | 2014-09-23 |
| Date of Event | 2014-09-22 |
| Date Mfgr Received | 2014-09-23 |
| Date Added to Maude | 2014-10-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 |
| Manufacturer City | SANTO DOMINGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLTPRT PLUS 5MM-12MM TRC W/BLTGRP |
| Generic Name | DISPOSABLE SURGICAL ACCESS DEVICE |
| Product Code | GDH |
| Date Received | 2014-10-17 |
| Model Number | 179075P |
| Catalog Number | 179075P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 SANTO DOMINGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-17 |