MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-13 for DEROYAL 28-0213NS manufactured by Deroyal Stone Bldg Technologies.
[19685811]
During a laparoscopic appendectomy, the insufflation tubing continually read restrictive flow. The tubing was replaced with different tubing and the surgery continued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015542 |
| MDR Report Key | 1661541 |
| Date Received | 2010-04-13 |
| Date of Report | 2010-04-13 |
| Date of Event | 2010-03-19 |
| Date Added to Maude | 2010-04-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | INSUFFLATION TUBING |
| Product Code | NKC |
| Date Received | 2010-04-13 |
| Model Number | 28-0213NS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL STONE BLDG TECHNOLOGIES |
| Manufacturer Address | 1601 HWY 33 SOUTH NEW TAZEWELL TN 37825 US 37825 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-04-13 |