MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-08-05 for PUR-WRAP 25-806 1 PD manufactured by Puritan Medical Products Company Llc.
[4905382]
Tip fell off swab during vaginal exam, samples are not available.
Patient Sequence No: 1, Text Type: D, B5
[12180245]
Batch records and retention samples were examined. No anomalies were noted. The device was not returned for eval. Mechanical test on the retained samples from the suspect lots has been performed: all the tested swabs were normal. We are unable to determine a root cause for the reported event. Our investigation could not confirm any malfunction or defect in the device lots associated with this incident. This is the (b)(4) swabs manufactured each year.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216735-2014-00001 |
| MDR Report Key | 4041730 |
| Report Source | 07 |
| Date Received | 2014-08-05 |
| Date of Report | 2014-07-30 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-07-30 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2014-09-03 |
| 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. P.O. BOX 149 |
| 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 | PUR-WRAP |
| Generic Name | ABSORBENT TIPPED APPLICATOR |
| Product Code | KXG |
| Date Received | 2014-08-05 |
| Model Number | 25-806 1 PD |
| Catalog Number | 25-806 1 PD |
| Lot Number | 3425 OR 3503 |
| ID Number | 04/01/2018 |
| 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 COMPANY LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-05 |