MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-06-06 for BLUNTPORT 5MM - 12MM TROCAR W/FOAMGRIP 176626 manufactured by Covidien.
[16686087]
Procedure type: gynecology. According to the reporter: about 10 years ago, the patient had the endometriosis procedure. Product id 176626 was used in the case. The patient complained about pain in abdomen recently, the examination was performed on (b)(6) 2014. Then a tumor mass was found by ct scanning and further by x-ray imaging a thin sheet of foreign material was confirmed, which the customer considers as a cause to develop the tumor. The size of foreign material was w: 1cm and l: 1. 5cm. Only this piece is returned from customer for investigations to identify if it came from the 176626 or not. The clinical sample of the concerning device is not available. Reported no other device of our product was used in the case. Operating time not extended. Tissue damage: yes. Pieces fell into the cavity and could be retrieved. No bleeding.
Patient Sequence No: 1, Text Type: D, B5
[16847615]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2014-00172 |
| MDR Report Key | 3876473 |
| Report Source | 01,06 |
| Date Received | 2014-06-06 |
| Date of Report | 2014-05-19 |
| Date of Event | 2014-03-06 |
| Date Mfgr Received | 2014-05-19 |
| Date Added to Maude | 2014-06-18 |
| 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, QA |
| 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 | BLUNTPORT 5MM - 12MM TROCAR W/FOAMGRIP |
| Generic Name | DISPOSABLE SURGICAL ACCESS DEVICE |
| Product Code | GDH |
| Date Received | 2014-06-06 |
| Catalog Number | 176626 |
| 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 SANTO DOMINGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-06 |