MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-04-21 for VALUE PACK (K-MART) SWAB 03672 manufactured by American White Cross, Inc..
[55316]
User was cleaning ear with cotton swab when tip dislodged in ear canal. Required medical attention to remove swab tip from ear canal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218939-1997-00008 |
| MDR Report Key | 87879 |
| Report Source | 04 |
| Date Received | 1997-04-21 |
| Date of Report | 1997-04-21 |
| Date of Event | 1996-07-11 |
| Date Facility Aware | 1997-04-14 |
| Report Date | 1997-04-21 |
| Date Mfgr Received | 1997-04-14 |
| Date Added to Maude | 1997-05-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALUE PACK (K-MART) SWAB |
| Generic Name | COTTON TIPPED SWAB |
| Product Code | FXF |
| Date Received | 1997-04-21 |
| Model Number | NA |
| Catalog Number | 03672 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 87008 |
| Manufacturer | AMERICAN WHITE CROSS, INC. |
| Manufacturer Address | 349 LAKE RD. DAYVILLE CT 06241 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-04-21 |