MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-11-03 for BLTPRT PLUS 5MM-12MM TRC W/BLTGRP 179075P manufactured by Covidien.
[4976147]
Procedure: lap appendectomy. According to the reporter: the port was inserted as usual with no apparent problems noted at the time of insertion. During surgery, after removing the port, it was found to have a crack in the end of it. It appeared to be just a crack, with no apparent piece of plastic missing.
Patient Sequence No: 1, Text Type: D, B5
[12406088]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2014-00387 |
| MDR Report Key | 4220673 |
| Report Source | 01,06 |
| Date Received | 2014-11-03 |
| Date of Report | 2014-10-24 |
| Date of Event | 2014-10-19 |
| Date Mfgr Received | 2014-10-24 |
| Device Manufacturer Date | 2014-05-16 |
| Date Added to Maude | 2014-11-17 |
| 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 | 0 |
| 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 | 2014-11-03 |
| Model Number | 179075P |
| Catalog Number | 179075P |
| Lot Number | J4E0134X |
| Device Expiration Date | 2019-05-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2014-11-03 |