MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-04-12 for KENDALL 41589 manufactured by Covidien.
[72652343]
Submit date: 04/12/2017 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
[72652344]
The customer states that the sponge was coming off the stick during a surgical procedure. The doctors had to retrieve the sponge from the patient's body twice. Although there was patient involvement the customer reported that no patient injury occurred.
Patient Sequence No: 1, Text Type: D, B5
[113061506]
There were no samples submitted with this complaint. The complaint shall be reopened if a sample is received. The device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements. There was no physical sample received for this report therefore the root cause of the reported condition stated by the customer could not be determined. As no physical samples were received for evaluation, the root cause of the reported condition stated by the customer could not be determined and subsequently no formal investigation actions are being taken at this time. Should a sample be returned in the future, the complaint shall be re-evaluated at that time. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2017-05055 |
| MDR Report Key | 6487627 |
| Report Source | USER FACILITY |
| Date Received | 2017-04-12 |
| Date of Report | 2018-02-20 |
| Date of Event | 2017-02-27 |
| Date Mfgr Received | 2017-03-14 |
| Date Added to Maude | 2017-04-12 |
| 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 |
| 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 | 2017-04-12 |
| Model Number | 41589 |
| Catalog Number | 41589 |
| Lot Number | 6285109264X |
| Device Expiration Date | 2019-08-31 |
| 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 TIJUANA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-12 |