MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-16 for HEGAR DILATOR GL 1401-010 manufactured by Cardinal Health.
[1413483]
Outpatient laparoscopy performed at outpatient facility. After the procedure, when the dilator that had been used in the case was being cleaned, it was noticed that it had a chip or hole in the tip. At that time the pt had already been discharged. However, the md and his practice rn followed up with the pt after being made aware of event. The pt is doing very well and denied any pain, abdominal distention, fever, bleeding, or discharge. The md & circulating rn were of the opinion that the chip in the dilator was present prior to the procedure (due to a small amount of bleeding noted by the md during the procedure, which was unexpected). Manufacturer response (as per reporter) for dilator, hegar dilator:to our sales representative's knowledge this had never occurred before and they would like to conduct testing for qa.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1576052 |
| MDR Report Key | 1576052 |
| Date Received | 2009-12-16 |
| Date of Report | 2009-12-16 |
| Date of Event | 2009-12-07 |
| Report Date | 2009-12-16 |
| Date Reported to FDA | 2009-12-16 |
| Date Added to Maude | 2010-01-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEGAR DILATOR |
| Generic Name | DILATOR |
| Product Code | HDQ |
| Date Received | 2009-12-16 |
| Model Number | GL 1401-010 |
| Catalog Number | GL 1401-010 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MEDICAL PRODUCTS & SERVICES/V. 1430 WAUKEGAN ROAD MCGAW PARK IL 60085678 US 60085 6787 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-16 |