MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-27 for UNK POLSORB SULU manufactured by Davis & Geck Caribe Ltd.
[74021045]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[74021046]
During gastric bypass (laparoscopic) procedure suture was unable to stay in the jaws of endostitch. There was no harm to patient, patient status: alive: no injury.
Patient Sequence No: 1, Text Type: D, B5
[121773088]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2017-05398 |
| MDR Report Key | 6526856 |
| Date Received | 2017-04-27 |
| Date of Report | 2017-03-30 |
| Date of Event | 2017-03-30 |
| Date Mfgr Received | 2017-03-30 |
| Date Added to Maude | 2017-04-27 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| 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 | 0 |
| Product Code | GAO |
| Date Received | 2017-04-27 |
| Model Number | UNK POLSORB SULU |
| Catalog Number | UNK POLSORB SULU |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-04-27 |