MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-06-11 for BLPRT PLUS 5MM-12MM TRC W/ FOAMGRP 176626P manufactured by Covidien.
[5944219]
According to the reporter: the foam collar fell into the abdomen and was recovered just before they began to close. When i asked the surgeon about it, she said it was a very complicated case with a large patient and the issue was not the result of a product failure. Patient status is good. The difficulty did not result in a unintended colostomy, formal laparotomy, re-operation etc. There was no unanticipated tissue loss. The incision was not extended by more than one inch. There was no unanticipated blood loss of 500cc or more. Surgery time was not delayed by more than 30 minutes. Foam collar on trocar fell into the patient and was retrieved.
Patient Sequence No: 1, Text Type: D, B5
[13369914]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2015-00307 |
| MDR Report Key | 4838584 |
| Report Source | 06 |
| Date Received | 2015-06-11 |
| Date of Report | 2015-06-02 |
| Date of Event | 2015-06-02 |
| Date Mfgr Received | 2015-06-02 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2015-07-09 |
| 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 | BLPRT PLUS 5MM-12MM TRC W/ FOAMGRP |
| Generic Name | DISPOSABLE SURGICAL ACCESS DEVICE |
| Product Code | GDH |
| Date Received | 2015-06-11 |
| Model Number | 176626P |
| Catalog Number | 176626P |
| Lot Number | J5C1759X |
| 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 | 2015-06-11 |