MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-05-23 for MEDICHOICE WOD5001 manufactured by Dalian Goodwood Medical Care Ltd..
[21260966]
The medical device associated with this report is a non-sterile, rayon-fiber tipped applicator (ob/gyn) consisting of a plastic stick and the rayon-fiber bud. It was communicated that the fiber head was falling off and being left behind in the vaginal wall. The manufacturer stated that in (b)(6) 2011 they reduced the concentration of glue which was used to secure the rayon tip to the plastic shaft. The low concentration of glue used to secure the rayon tip to the plastic shaft was determined to be the most probable root cause of the fiber head falling off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003753847-2013-00014 |
| MDR Report Key | 3131079 |
| Report Source | 99 |
| Date Received | 2013-05-23 |
| Date of Report | 2013-02-20 |
| Date Facility Aware | 2013-02-20 |
| Report Date | 2013-05-23 |
| Date Reported to FDA | 2013-05-23 |
| Date Reported to Mfgr | 2013-05-23 |
| Date Added to Maude | 2013-05-29 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Manufacturer Street | 9120 LOCKWOOD BLVD |
| Manufacturer City | MECHANICSVILLE VA 231160000 |
| Manufacturer Country | US |
| Manufacturer Postal | 231160000 |
| Manufacturer G1 | OWENS MINOR DISTRIBUTION INC. |
| Manufacturer Street | 9120 LOCKWOOD BLVD |
| Manufacturer City | MECHANICSVILLE VA 23116000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 23116 0000 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICHOICE |
| Generic Name | RAYON TIPPED OB/GYN APPLICATOR |
| Product Code | HGD |
| Date Received | 2013-05-23 |
| Catalog Number | WOD5001 |
| Lot Number | 1211DG13A |
| Device Expiration Date | 2017-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DALIAN GOODWOOD MEDICAL CARE LTD. |
| Manufacturer Address | 3-91 JIULICUN YONGZHENG STREET JINZHOU DISTRICT DALIAN 116100 CH 116100 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-05-23 |