MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-15 for LEEP PEDERSEN SPEC LARGE 61519 manufactured by Coopersurgical, Inc..
[108360371]
Coopersurgical, inc. 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
[108360372]
The patient has been burnt on both side of her vaginal area- according to (b)(6) - this is one of their sister locations and she believes that it could of been a user error... The nurse to update us on this - (b)(6). Update: we spoke to (b)(6), the nurse who had documentation regarding the incident (hippa) burns on either side of the v walls, no affects on the anti/posterior- 1 center in diameter. Sent pt with medication/etc... They have the pt coming back in 2-weeks, not sure for the same procedure. (b)(6). 4. Please describe what was observed. 2 speculum burn marks, one on the inside left vaginal wall and one on the inside right vaginal wall post leep procedure. Blue insulated instruments were used during case. Patients left side was greater than the right side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2018-00025 |
| MDR Report Key | 7516210 |
| Date Received | 2018-05-15 |
| Date of Report | 2018-05-15 |
| Date of Event | 2018-03-20 |
| Date Mfgr Received | 2018-03-26 |
| Date Added to Maude | 2018-05-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | LEEP PEDERSEN SPEC LARGE |
| Generic Name | LEEP PEDERSEN SPEC LARGE |
| Product Code | HDF |
| Date Received | 2018-05-15 |
| Returned To Mfg | 2018-04-17 |
| Model Number | 61519 |
| Catalog Number | 61519 |
| Lot Number | NOT APPLICABLE |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-05-15 |