MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-27 for MESH, SURGICAL manufactured by Baxter Healthcare Corporation.
[185225152]
(b)(6) 2002 to (b)(6) 2003. The reported product is an unknown baxter peri-strip. Literature article: s. Yu, k. Jastrow, b. Clapp, l. Kao, c. Klein, t. Scarborough, e. Wilson. ? Foreign material erosion after laparoscopic roux-en-y gastric bypass: findings and treatment?. Surg endosc (2007) 21: 1216? 1220; doi: 10. 1007/s00464-007-9328-3. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185225153]
It was reported 153 patients underwent a two-year study in which peri-strips were used with laparoscopic roux-en-y gastric bypass. Six patients experienced post-operative events with incidence of foreign material erosion into the gastric pouch. One patient experienced a gastro-jejunal anastomotic leak and was? Treated conservatively?. Three patients experienced strictures, four patients experienced marginal ulcerations, 13 patients experienced nausea, 12 patients experienced vomiting, three patients experienced melena, five patients experienced dysphagia and 15 patients experienced abdominal pain. Treatment for the events was not reported. The study reported the? Patient outcomes were determined by resolution of symptoms, improvement of symptoms, or no effect or worsening of symptoms at follow-up? (no further details). No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01775 |
| MDR Report Key | 9888535 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-27 |
| 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 Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Street | 2575 UNIVERSITY AVE W |
| Manufacturer City | SAINT PAUL MN 55114 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55114 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NI |
| Generic Name | MESH, SURGICAL |
| Product Code | FTM |
| Date Received | 2020-03-27 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-27 |