MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-28 for MX5030 TRIMO SAN manufactured by Coopersurgical, Inc..
[44579637]
Coopersurgical inc. Is currently investigating the reported complaint condition. Once the investigation is completed a follow-up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[44579638]
Patient reported white cottage cheese chunk vaginal discharge after 4 weeks of use twice weekly for a total of 7 tubes. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[55340789]
Reference e-complaint: (b)(4). Investigation, x-initiated manufacturer's investigation, x-no sample returned, review dhr, inspect returned samples, inspect stock product. Analysis and findings: dhr review could not be performed as the subject lot was not provided. A two year review of manufacturing records did not show any related manufacturing issues during the last 2 years. There have not been any related product design or product specification changes in the last two years. Historical review of complaint files did not show any related complaints. A follow up to the secondary reporter, church and dwight, did not yield any additional information. The complainant however indicated she previously did not have any discharge and had used about 7 trimo-san? Vaginal jelly tubes in a span of 4 weeks prior to the alleged event. The patient was advised by her doctor to reduce the application of the trimo-san? Vaginal jelly to twice a week to help manage her uterine prolapse. Assignable cause could not be determined based on the information provided. There was no patient injury reported. There has not been any additional information received since. Based on overall complaint history, product knowledge, and the reported complaint condition, it is unlikely the reported complaint condition would result in any adverse event. The discharge may have been due to over application of the trimo-san? Vaginal jelly. No further actions are needed at this time. Coopersurgical will continue to monitor complaints of this nature for any adverse trends. Correction and/or corrective action: no further actions are needed at this time. Corrective action level: 4, x-none. Was the complaint confirmed? No. Review and closure. Preventative action activity reviewed. Trend and monitor to cip.
Patient Sequence No: 1, Text Type: N, H10
[55340790]
Patient reported white cottage cheese chunk vaginal discharge after 4 weeks of use twice weekly for a total of 7 tubes. Reference e-complaint number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2016-00014 |
| MDR Report Key | 5614242 |
| Date Received | 2016-04-28 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-01-22 |
| Date Added to Maude | 2016-04-28 |
| 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 | 3 |
| Manufacturer Contact | MR. NANA BANAFO |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MX5030 TRIMO SAN |
| Generic Name | MX5030 TRIMO SAN |
| Product Code | KMJ |
| Date Received | 2016-04-28 |
| Model Number | MX5030 |
| Catalog Number | MX5030 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 75 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-28 |