MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-18 for KOH-EFFICIENT,ARCH,4.0CM KC-ARCH-40 manufactured by Coopersurgical, Inc..
[131744419]
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
[131744420]
"dr. (b)(6) performed a lsh on a patient using a rumi koh 4. 0 in march. She skipped her follow up appointment and then came in last week complaining of a smell and discomfort. Dr. (b)(6) couldn't take what he thought looked like a rumi cup out without causing the patient pain. They had booked an appointment for (b)(6) 2018 to remove the object, but it fell out on friday (b)(6). She came in to get checked out on (b)(6) and everything looked good. He said he found a small piece of what looked like a thick glove. He doesn't think it looks like a piece of the occluder balloon. He showed the patient a picture of the koh efficient and she didn't think that was it. She asked dr. (b)(6) about suing. She showed him a picture of the object that fell out and he said it didn't look like the koh efficient but maybe a piece of the koh efficient. I showed him a koh efficient and let him rip it apart. He doesn't see anything on the koh efficient that looks like the picture she showed him. He just doesn't know what else could be a cooper blue plastic that would be in her vagina. She was going to drop of the object but has not yet. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2018-00086 |
| MDR Report Key | 8174608 |
| Date Received | 2018-12-18 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-11-23 |
| Date Mfgr Received | 2018-11-23 |
| Date Added to Maude | 2018-12-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PETER NIZIOLEK |
| Manufacturer Street | 50 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL DE 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 | 0 |
| Brand Name | KOH-EFFICIENT,ARCH,4.0CM |
| Generic Name | KOH-EFFICIENT,ARCH,4.0CM |
| Product Code | HEW |
| Date Received | 2018-12-18 |
| Model Number | KC-ARCH-40 |
| Catalog Number | KC-ARCH-40 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-18 |