MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2006-12-20 for PURITAN NP SWABS 25-1406 1PFB 100/10 manufactured by Puritan Medical Products Llc..
[20893837]
The nasopharyngeal swab tip detached from the shaft, while getting a "pn" sample. The physician could not see or remove the foam tip.
Patient Sequence No: 1, Text Type: D, B5
[21188141]
The np swab included in the binay now influenza a&b kit is a packaged component purchased from puritan medical products co, llc. Puritan was contacted and was informed of this adverse incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221359-2006-00002 |
| MDR Report Key | 798403 |
| Report Source | 04,05,06 |
| Date Received | 2006-12-20 |
| Date of Report | 2006-12-13 |
| Date of Event | 2006-11-29 |
| Date Mfgr Received | 2006-11-29 |
| Date Added to Maude | 2006-12-28 |
| 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 | 0 |
| Manufacturer Street | 10 SOUTHGATE RD |
| Manufacturer City | SCARBOROUGH ME 04074 |
| Manufacturer Country | US |
| Manufacturer Postal | 04074 |
| Manufacturer Phone | 2077305740 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PURITAN NP SWABS |
| Generic Name | NASOPHARYNGEAL SWABS |
| Product Code | KCJ |
| Date Received | 2006-12-20 |
| Model Number | NA |
| Catalog Number | 25-1406 1PFB 100/10 |
| Lot Number | 8995 |
| ID Number | NA |
| Device Expiration Date | 2011-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 785932 |
| Manufacturer | PURITAN MEDICAL PRODUCTS LLC. |
| Manufacturer Address | * GUILFORD ME * US |
| Baseline Brand Name | PURITAN NP SWABS |
| Baseline Generic Name | NASOPHARYNGEAL SWABS |
| Baseline Model No | NA |
| Baseline Catalog No | 25-1406 1PFB 100/10 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-12-20 |