MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-14 for PURITAN 25-806 1PR manufactured by Puritan Medical Products Co Llc.
[21800703]
Nurse was swabbing pediatric pt for strep, the child bit down on swab and it broke off in the mouth, but nurse was able to remove from pt's mouth without issue. With the same pt, a new test was opened and the nurse attempted to swab the pt again, the pt bit down close to the head of the swab and the loose piece of swab became lodged in the pt's throat. The heimlich maneuver had to be performed on the pt to remove the loose piece of swab.
Patient Sequence No: 1, Text Type: D, B5
[22282938]
This is the first report of shaft fracture from biting in over 10 years of complaint trend analysis. Our investigation of the report included review of the batch records and inspection of retention samples. The investigation did not reveal any out of specification testing or process deviations. The event is recorded in our system and we will monitor our field complaints for similar events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216735-2015-00001 |
| MDR Report Key | 4729697 |
| Report Source | 05 |
| Date Received | 2015-04-14 |
| Date of Report | 2015-04-02 |
| Date of Event | 2015-03-02 |
| Date Mfgr Received | 2015-03-02 |
| Device Manufacturer Date | 2013-03-03 |
| Date Added to Maude | 2015-06-08 |
| 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 | WILLIAM YOUNG |
| Manufacturer Street | 31 SCHOOL ST |
| Manufacturer City | GUILFORD ME 04443 |
| Manufacturer Country | US |
| Manufacturer Postal | 04443 |
| Manufacturer Phone | 2078763311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PURITAN |
| Generic Name | STERILE ABSORBENT TIPPED APPLICATOR |
| Product Code | KXG |
| Date Received | 2015-04-14 |
| Model Number | 25-806 1PR |
| Catalog Number | 25-806 1PR |
| Lot Number | 3396 |
| ID Number | 38014 |
| Device Expiration Date | 2018-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PURITAN MEDICAL PRODUCTS CO LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-14 |