MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-24 for TRIMO SAN MX5030 manufactured by Coopersurgical, Inc..
[65945333]
Coopersurgical, inc. Is currently investigating the reported complaint condition. The device involved in the complaint will not be returned by the patient for evaluation. Once the investigation is complete, a follow up report will be filed. (b)(4). Product will not be returned.
Patient Sequence No: 1, Text Type: N, H10
[65945334]
(b)(4). "caller stated that she is a user of the device and knew immediately that her applicator has a sharp opening, said she ran her hand across the opening and could feel its sharpness. Customer stated she used it anyway but tried to use it in a way that the could avoid the sharp opening scrapping against her skin but was unfortunate. She is a bit sore border line aching feather line blood. Caller states when wiping a bit of dark tint can be seen caller also stated that she will watch aching for a week and if symptoms are still present she will make an appointment to see obgyn"
Patient Sequence No: 1, Text Type: D, B5
[66839272]
Coopersurgical, inc. Is currently investigating the reported complaint condition. The device involved in the complaint will not be returned by the patient for evaluation. Once the investigation is complete, a follow up report will be filed. Reference e-complaint (b)(4) *** follow up 02/07/2017 *** investigation: initiated manufacturer's investigation. X-no sample returned. X-review dhr. Inspect returned samples. X-inspect stock product. *analysis and findings: an evaluation of the complainant samples could not be conducted since they will not be returned. The applicator assembly is made up of three component parts (the bulb, the flyer and the tube) purchased from and assembled by a supplier. A review of two year complaint history shows no complaints for this issue. A review of the dhr's ((b)(4)) show no abnormalities. A review of coopersurgical incoming inspection records shows no rejections for this issue. The tube is molded by a supplier and has 8 cavities. A sample of all 8 cavities in stock inventory found all the parts met quality requirements and were not sharp at the distal end. The reported complaint could not be confirmed. *correction and/or corrective action should the samples be returned, this complaint will be reopened and re-evaluated. This complaint will be entered into the cooper surgical continuous improvement plan (cip).
Patient Sequence No: 1, Text Type: N, H10
[66839273]
Reference e-complaint (b)(4). "caller stated that she is a user of the device and knew immediately that her applicator has a sharp opening, said she ran her hang across the opening and could feel its sharpness. Customer stated she used it anyway but tried to use it in a way that the could avoid the sharp opening scrapping against her skin but was unfortunate. She is a bit sore border line aching feather line blood. Caller states when wiping a bit of dark tint can be seen caller also stated that she will watch aching for a week and if symptoms are still present she will make an appointment to see obgyn"
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2017-00002 |
| MDR Report Key | 6272560 |
| Date Received | 2017-01-24 |
| Date of Report | 2017-01-24 |
| Date of Event | 2016-12-13 |
| Date Mfgr Received | 2016-12-14 |
| Date Added to Maude | 2017-01-24 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | TRIMO SAN |
| Generic Name | TRIMO SAN |
| Product Code | HGD |
| Date Received | 2017-01-24 |
| Model Number | MX5030 |
| Catalog Number | MX5030 |
| Lot Number | 5890 |
| Device Expiration Date | 2018-03-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-01-24 |