MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2009-02-05 for TRAY WET SKIN SCRB/SM WING SPG 41589 manufactured by Covidien.
[1040332]
It was reported to covidien in early 2009 that a customer had an issue with a wet skin scrub kit. The customer stated that the sponge used to prep the inside of the vagina is coming off of the stick.
Patient Sequence No: 1, Text Type: D, B5
[8166980]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2009-00003 |
| MDR Report Key | 1309689 |
| Report Source | 06,07 |
| Date Received | 2009-02-05 |
| Date of Report | 2009-01-28 |
| Report Date | 2009-01-28 |
| Date Reported to Mfgr | 2009-01-28 |
| Date Mfgr Received | 2009-01-28 |
| Date Added to Maude | 2009-07-01 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | JILL SARAIVA |
| Manufacturer Street | 115 HAMPHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524970 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 9255 CUSTOMHOUSE PLAZA SUITE A |
| Manufacturer City | SAN DIEGO CA 92173 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRAY WET SKIN SCRB/SM WING SPG |
| Generic Name | WET SKIN SCRUB TRAY |
| Product Code | GEC |
| Date Received | 2009-02-05 |
| Model Number | 41589 |
| Catalog Number | 41589 |
| Lot Number | 819986264 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 9255 CUSTOMHOUSE PLAZA SUITE A SAN DIEGO CA 92173 US 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-05 |