MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-08-25 for KENDALL 41590 manufactured by Covidien.
[83732600]
(b)(6) 2017 an investigation is currently underway. Upon completion, the results will be forwarded. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[83732601]
The customer states that the sponge tip piece had detached inside the patient and had to be retrieved by staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2017-05148 |
| MDR Report Key | 6822741 |
| Report Source | USER FACILITY |
| Date Received | 2017-08-25 |
| Date of Report | 2018-01-26 |
| Date of Event | 2017-07-25 |
| Date Mfgr Received | 2017-07-26 |
| Device Manufacturer Date | 2016-10-18 |
| Date Added to Maude | 2017-08-25 |
| 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. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA 92173 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENDALL |
| Generic Name | BRUSH, SCRUB, OPERATING-ROOM |
| Product Code | GEC |
| Date Received | 2017-08-25 |
| Returned To Mfg | 2017-08-11 |
| Model Number | 41590 |
| Catalog Number | 41590 |
| Lot Number | 6285109364X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-25 |