MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-04-11 for DOVER 6165LL manufactured by Mitg - Kenmex.
[105413092]
A device history record review could not be performed because a lot number was not received with the complaint. As part of our manu facturing process, all device history records are reviewed and approved by quality, prior to release of product. Because a sample was not returned, we were unable to perform a thorough follow up investigation to include functional and visual evaluations to confirm the reported issue and root cause analysis. It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations. If additional information is obtained, or the sample is returned, this file will be re-opened for further investigation. This complaint will be used for qa tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[105413093]
Customer reports: the patient had a foley catheter inserted and upon removal, the balloon would not deflate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2018-00057 |
| MDR Report Key | 7422692 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-11 |
| Date of Report | 2018-04-11 |
| Date of Event | 2018-03-30 |
| Date Mfgr Received | 2018-04-09 |
| Date Added to Maude | 2018-04-11 |
| 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 | MITG - KENMEX |
| 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 | DOVER |
| Generic Name | KIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER |
| Product Code | FCN |
| Date Received | 2018-04-11 |
| Model Number | 6165LL |
| Catalog Number | 6165LL |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MITG - KENMEX |
| Manufacturer Address | CALLE 9 SUR NO. 1113 CUIDAD TIJUANA,NA 22444 MX 22444 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-11 |