MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature,user facility report with the FDA on 2017-09-12 for KENDALL 41589 manufactured by Covidien.
[85783595]
Submit date: (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
[85783596]
The customer reports that part of it keeps coming off from the body. There was no patient harm as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
[113256310]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[113256311]
The customer stated that the sponge head of the stick did completely come off inside of the vagina. The case was a obgyn case. It was a dilation and curettage. The sponge head was retrieved with a pair of sponge forceps.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2017-05162 |
| MDR Report Key | 6858162 |
| Report Source | LITERATURE,USER FACILITY |
| Date Received | 2017-09-12 |
| Date of Report | 2018-01-19 |
| Date of Event | 2017-04-03 |
| Date Mfgr Received | 2017-04-03 |
| Date Added to Maude | 2017-09-12 |
| 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 | 2017-09-12 |
| Model Number | 41589 |
| Catalog Number | 41589 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-09-12 |