MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-06-23 for PURITAN COTTON TIPPED WOOD APPLICATOR 803-WC manufactured by Puritan Medical Products Co. Llc.
[48056764]
The actual sample was not returned for evaluation. Without an actual sample, a root cause has not been determined. Batch production records were reviewed and no anomalies were detected. We annually produce over (b)(4) 3-inch and (b)(4) 6-inch cotton tipped wood applicators for more than 10 years. This is the first complaint of this nature documented from this market history. Procedures are in place to inspect cotton fiber bud density. This incident is recorded in our trend analysis system and we will monitor for similar events. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[48056765]
The facility reported that the cotton tip applicator left lint on the incision site during blepharoplasty. The lint was washed from the site. No injury resulted. No further intervention was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216735-2016-00001 |
| MDR Report Key | 5745311 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-06-23 |
| Date of Report | 2016-04-27 |
| Date Mfgr Received | 2016-03-30 |
| Device Manufacturer Date | 2015-08-03 |
| Date Added to Maude | 2016-06-23 |
| 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 | MR WILLIAM YOUNG |
| Manufacturer Street | 31 SCHOOL STREET PO BOX 149 |
| Manufacturer City | GUILFORD ME 044430149 |
| Manufacturer Country | US |
| Manufacturer Postal | 044430149 |
| Manufacturer Phone | 2078763311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PURITAN COTTON TIPPED WOOD APPLICATOR |
| Generic Name | SWAB |
| Product Code | KXF |
| Date Received | 2016-06-23 |
| Model Number | 803-WC |
| Catalog Number | 803-WC |
| Lot Number | 18558 OR 18485 |
| Device Expiration Date | 2016-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PURITAN MEDICAL PRODUCTS CO. LLC |
| Manufacturer Address | 31 SCHOOL STREET PO BOX 149 GUILFORD ME 044430149 US 044430149 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-23 |