MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-02-19 for COTTON TIP APPLICATOR MDS202000 manufactured by Medline Industries, Inc..
[4318389]
The cotton tip came off of the applicator during a surgical procedure. The tip was retrieved from the surgical site.
Patient Sequence No: 1, Text Type: D, B5
[11636847]
During a laparoscopic appendectomy, the surgeon inserted the cotton tip applicator into the trochar to clean the opening. The cotton came off the tip and was retrieved from the surgical site. There was no injury or need for further intervention. The sample was discarded by the facility and not available for evaluation. We have no photo or lot number of the device involved in the incident. A root cause has not been determined. We have had no other similar incidents reported to us for this device in the past year.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00012 |
| MDR Report Key | 3652955 |
| Report Source | 05,06 |
| Date Received | 2014-02-19 |
| Date of Report | 2014-02-10 |
| Date of Event | 2013-10-22 |
| Date Mfgr Received | 2014-01-16 |
| Date Added to Maude | 2014-03-04 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COTTON TIP APPLICATOR |
| Product Code | KXG |
| Date Received | 2014-02-19 |
| Catalog Number | MDS202000 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-19 |