MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1997-03-28 for 1219930CE SOFTRANS IUPC IUP 4000 31103826 manufactured by Graphic Controls Corp..
[18600818]
A resident was inserting an iupc in a woman during labor and the uterus was allegedly perforated. The initial reporter felt this was a user related issue and not related to the product because she has seen this happen before with residents that don't know how to handle the product. The initial reporter did not know why the resident was inserting an iupc. But apparently he met some resistance and then pushed it forward a little bit more and it went in. After insertion of the iupc the pt had severe pain and it was realized that the uterus may have been perforated by the iupc. The pt had a stat c-section to deliver the baby and a repair for a perforation of the uterus. The pt and baby were reported to be fine afterwards. The actual device used was discarded and therefore could not be evaluated by the mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243963-1997-00001 |
| MDR Report Key | 80380 |
| Report Source | 05,06,07 |
| Date Received | 1997-03-28 |
| Date of Report | 1997-02-28 |
| Date of Event | 1997-02-25 |
| Date Facility Aware | 1997-02-25 |
| Report Date | 1997-02-28 |
| Date Mfgr Received | 1997-02-28 |
| Date Added to Maude | 1997-04-03 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1219930CE SOFTRANS IUPC |
| Generic Name | 1996AUTERINE PRESSURE CATHETER |
| Product Code | KXO |
| Date Received | 1997-03-28 |
| Model Number | IUP 4000 |
| Catalog Number | 31103826 |
| Lot Number | 101196T |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 79844 |
| Manufacturer | GRAPHIC CONTROLS CORP. |
| Manufacturer Address | 1 CARNEGIE PLAZA CHERRY HILL NJ 08003 US |
| Baseline Brand Name | LIFETRACE SOFTRANS IUPC |
| Baseline Generic Name | INTRAUTERINE PRESSURE CATHETER |
| Baseline Model No | IUP 4000 |
| Baseline Catalog No | 31103826 |
| Baseline ID | NA |
| Baseline Device Family | INTRAUTERINE PRESSURE CATHETER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K950498 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-03-28 |