MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-20 for DILATION PRODUCTS UNK manufactured by C.r. Bard, Inc. (covington) -1018233.
[120878175]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[120878176]
It was reported that the balloon burst while in use on a patient. During surgery for a gyn procedure, the patient started having excess bleeding. As an intervention the surgeon used the device as a tamponade device. The bleeding came under control, the procedure ended and the patient was sent to recovery. While in recovery, the balloon burst. The patient was kept in recovery overnight and instead of being discharged, she was transported to another facility to have the remainder of the device removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-04285 |
| MDR Report Key | 7894065 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-20 |
| Date of Report | 2018-12-12 |
| Date Mfgr Received | 2018-12-06 |
| Date Added to Maude | 2018-09-20 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DILATION PRODUCTS |
| Generic Name | X-FORCE BALLOON DILATOR |
| Product Code | FBW |
| Date Received | 2018-09-20 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-09-20 |