MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for LH-SCOLPO-SML manufactured by Coopersurgical, Inc..
[135724155]
The complaint condition reported is currently being investigated by coopsersurgical, inc. Once the investigation has been completed a follow up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[135724156]
"the handle was removed from the patient but part of the tip stayed in. When it was placed on the mayo stand, it fell apart. Spoke with rep he said the tip was removed from the patient without injury. The broken product will not be returned. Just two of the same lot. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2019-00027 |
| MDR Report Key | 8312091 |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-06 |
| Date of Event | 2019-01-22 |
| Date Mfgr Received | 2019-01-23 |
| Device Manufacturer Date | 2018-12-07 |
| Date Added to Maude | 2019-02-06 |
| 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 | 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 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 | 0 |
| Brand Name | LH-SCOLPO-SML |
| Generic Name | LH-SCOLPO-SML |
| Product Code | HDL |
| Date Received | 2019-02-06 |
| Model Number | LH-SCOLPO-SML |
| Catalog Number | LH-SCOLPO-SML |
| Lot Number | 255108 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-02-06 |