MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-21 for DOVER 7016LL manufactured by Covidien.
[103137000]
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[103137001]
The customer reports that the patient had a foley catheter placed due to difficulty voiding after previous surgeries. Less than 12 hours post insertion, the nurse tried to deflate the balloon with a syringe, but the balloon would not deflate. The nurse then tried to cut the fill port and the balloon still did not drain. A urology md was brought to the department to try to manipulate the foley to get it to drain, however, was unable to do so. The patient had to be taken into surgery to have the foley catheter removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2018-00034 |
| MDR Report Key | 7359848 |
| Date Received | 2018-03-21 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-03-05 |
| Date Mfgr Received | 2018-03-13 |
| Date Added to Maude | 2018-03-21 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 1113 CUIDAD |
| Manufacturer City | TIJUANA,NA 22444 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22444 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DOVER |
| Generic Name | KIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER |
| Product Code | FCN |
| Date Received | 2018-03-21 |
| Model Number | 7016LL |
| Catalog Number | 7016LL |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 1113 CUIDAD TIJUANA,NA 22444 MX 22444 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-21 |