MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-11-29 for CONTOUR CORE SCULPTING SYSTEM M2 NA manufactured by Contour Technology.
[2401253]
Customer called our customer service center to "let us know" that she suffered an appendix attack which ruptured and she was hospitalized. Purchase date was (b)(6) 2011. On a subsequent call back, she stated that she was using the contour core sculpting system for months but noticed she had, what she thought was gas pains for 3 days and she sought medical attention. She was hospitalized and received an appendectomy and treated with antibiotics for a ruptured appendix. Customer stated that her daughter "threw the product away" during her hospital stay. She is fully recovered.
Patient Sequence No: 1, Text Type: D, B5
[9601191]
There is no evidence or confirmation that device played any role in injury. This was speculation from the customer. A refund was issued in spite of the device not being returned. Contour has closed this case due to lack of f/u material. Refund was issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006348601-2011-00001 |
| MDR Report Key | 2395051 |
| Report Source | 01 |
| Date Received | 2011-11-29 |
| Date of Report | 2011-11-14 |
| Date of Event | 2011-09-15 |
| Date Facility Aware | 2011-10-05 |
| Report Date | 2011-11-16 |
| Date Added to Maude | 2012-01-04 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 701 WING ON PLAZA, 62 MODY RD TSIM SHA TSUI EAST |
| Manufacturer City | KOWLOON |
| Manufacturer Country | HK |
| Manufacturer G1 | DISPLAYTECH LTD. |
| Manufacturer Street | 1501-2 EMPRESS PLZ, 17-19 CHATHAM RD S, TSIM SHA TSUI |
| Manufacturer City | KOWLOON |
| Manufacturer Country | HK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTOUR CORE SCULPTING SYSTEM |
| Generic Name | CONTOUR CORE BELT |
| Product Code | NGX |
| Date Received | 2011-11-29 |
| Model Number | M2 |
| Catalog Number | NA |
| Lot Number | NOT AVAILABLE |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONTOUR TECHNOLOGY |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-11-29 |