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 2018-05-29 for UNKNOWN FOLEY CATHETER UNK URO manufactured by Covidien.
[109449273]
Submit date: 5/29/2018. 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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[109449274]
Customer reports: the patient had a foley catheter inserted during labor and delivery. After delivery, the nursing staff attempted to remove the catheter by draining the balloon with a syringe. The balloon would not deflate. The staff then cut the fill port todrain the fluid from the balloon, but the balloon would not deflate. Finally, a md was called in and used a guidewire to pop the balloon which proved successful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2018-00097 |
| MDR Report Key | 7550577 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-29 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-05-07 |
| Date Mfgr Received | 2018-05-15 |
| Date Added to Maude | 2018-05-29 |
| 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 | 3 |
| Brand Name | UNKNOWN FOLEY CATHETER |
| Generic Name | CATHETER, URETERAL, GASTRO-UROLOGY |
| Product Code | EYB |
| Date Received | 2018-05-29 |
| Model Number | UNK URO |
| Catalog Number | UNK URO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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. Required No Informationntervention | 2018-05-29 |