MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-28 for POLYSORB 170056 manufactured by Davis & Geck Caribe Ltd.
[176620024]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[176620025]
According to the reporter, eight weeks postoperative from total laparoscopic hysterectomy, patient had cuff dehiscence. Revision of vaginal cuff was performed to resolve the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612501-2020-00159 |
| MDR Report Key | 9637846 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2019-04-17 |
| Date Added to Maude | 2020-01-28 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | DAVIS & GECK CARIBE LTD |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO |
| Manufacturer City | SANTO DOMINGO 0101 |
| Manufacturer Country | DO |
| Manufacturer Postal Code | 0101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYSORB |
| Generic Name | ENDOSCOPIC TISSUE APPROXIMATION DEVICE |
| Product Code | OCW |
| Date Received | 2020-01-28 |
| Model Number | 170056 |
| Catalog Number | 170056 |
| Lot Number | J9D1628Y |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVIS & GECK CARIBE LTD |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO SANTO DOMINGO 0101 DO 0101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-28 |