MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-17 for ALBA HEALTH TERRY TREDS * manufactured by Alba Health, Quality Division, Division Encompass Group.
[20527302]
Pt in for out-patient surgery, changing into gown/booties, stepped on needle at toe. Originally thought to be a broken tip of suture needle. On further investigation determined to be broken tip of a sewing machine needle (possibly lodged in toe of bootie). Pt started on regimen of anti-viral drugs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1033798 |
| MDR Report Key | 559530 |
| Date Received | 2004-11-17 |
| Date of Report | 2004-11-08 |
| Date of Event | 2004-08-25 |
| Date Added to Maude | 2004-12-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALBA HEALTH TERRY TREDS |
| Generic Name | SEWING MACHINE NEEDLE TIP |
| Product Code | FXP |
| Date Received | 2004-11-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | MANUF# 93050 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 549233 |
| Manufacturer | ALBA HEALTH, QUALITY DIVISION, DIVISION ENCOMPASS GROUP |
| Manufacturer Address | * ADDISON TX 75001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-11-17 |