MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-13 for EURO-MED ROTATING HANDLE 64-649 manufactured by Coopersurgical, Inc..
[105767748]
Coopersurgical is currently investigating the reported condition. Once the investigation is complete, a follow up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[105767749]
"we are investigating an incident where a bar from a euromed rotating morgan tischler punch biopsy ref# (b)(4) - one of the bars detached during the biopsy and had to be retrieved as a foreign body from the patient. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2018-00014 |
| MDR Report Key | 7430358 |
| Date Received | 2018-04-13 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-02-28 |
| Date Mfgr Received | 2018-03-15 |
| Device Manufacturer Date | 2010-07-26 |
| Date Added to Maude | 2018-04-13 |
| 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 DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DR |
| 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 | EURO-MED ROTATING HANDLE |
| Generic Name | EURO-MED ROTATING HANDLE |
| Product Code | HFB |
| Date Received | 2018-04-13 |
| Model Number | 64-649 |
| Catalog Number | 64-649 |
| Lot Number | 1052 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2018-04-13 |