MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-08-15 for PLASTIC COTTON TIP APPLICATOR MDS202095 manufactured by Medline Industries, Inc..
[4843277]
The cotton tip fell off the applicator and was not retrieved.
Patient Sequence No: 1, Text Type: D, B5
[12003470]
Following abdominal surgery for colon cancer, the patient developed cellulitis of her incision. She cleaned the open surgical would twice daily with betadine and a cotton tip applicator. She reported the cotton tip came of the applicator and fell into the wound. The cotton tip was not retrieved. The patient was seen by her physician following the incident. The physician did not locate the cotton tip. She followed up with him again on (b)(6). He examined her again and was not able to locate the cotton tip or confirm its presence in the surgical wound. The sample was not returned for evaluation. We have not confirmed the issue or identified the root cause. However, in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00078 |
| MDR Report Key | 4036281 |
| Report Source | 04 |
| Date Received | 2014-08-15 |
| Date of Report | 2014-08-13 |
| Date of Event | 2014-07-09 |
| Date Mfgr Received | 2014-07-16 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2014-08-27 |
| 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 | 0 |
| Event Location | 0 |
| 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 | PLASTIC COTTON TIP APPLICATOR |
| Product Code | KXG |
| Date Received | 2014-08-15 |
| Catalog Number | MDS202095 |
| Lot Number | 506794406 |
| 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 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-15 |