MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2018-05-16 for BARD HEYMAN FOLLOWER COUDE TIP 12 FR., STERILE 021312 manufactured by C.r. Bard, Inc. (covington) -1018233.
[108451607]
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
[108451608]
It was reported that the tip was very blunt instead of having a smooth tapered end. The patient alleged significant damage to the urethral tissue. There was no change in the medical management of a patient that has a more traumatic dilation (damage to urethral tissue), except to leave the post-dilation catheter in longer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-01778 |
| MDR Report Key | 7519796 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2018-05-16 |
| Date of Report | 2018-07-06 |
| Date Mfgr Received | 2018-07-02 |
| Device Manufacturer Date | 2017-08-31 |
| Date Added to Maude | 2018-05-16 |
| 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 | AMY GRAVLEY |
| 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 | BARD HEYMAN FOLLOWER COUDE TIP 12 FR., STERILE |
| Generic Name | DILATION CATHETER |
| Product Code | FBW |
| Date Received | 2018-05-16 |
| Returned To Mfg | 2018-04-24 |
| Model Number | 021312 |
| Catalog Number | 021312 |
| Lot Number | MCBV6209 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2018-05-16 |