MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-03-01 for PROXIMATE I L S INTRALUMINAL STAPLER CDH29 manufactured by Ethicon Endo-surgery - Alb.
[146136]
It was reported by the rep that (1) cdh29 and the (1) tlc55 were used during a small bowel resection procedure. It was reported that (2) days post-operatively the pt had a very bloody bowel movement and fainted in the hosp bathroom. The pt was given whole packed blood and plasma without results. The pt was taken back to surgery, whereupon it was discovered that the staple line had been leaking. The pt was reoperated on, had reanastomosized, given antibiotics, and admitted to intensive care unit until stabilized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1527736-2000-00807 |
| MDR Report Key | 267137 |
| Report Source | 07 |
| Date Received | 2000-03-01 |
| Date of Report | 2000-02-23 |
| Date Mfgr Received | 2000-02-23 |
| Date Added to Maude | 2000-03-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN HUFF, MGR. |
| Manufacturer Street | 4545 CREEK ROAD |
| Manufacturer City | CINCINNATI OH 45242 |
| Manufacturer Country | US |
| Manufacturer Postal | 45242 |
| Manufacturer Phone | 5133377460 |
| Manufacturer G1 | ETHICON ENDO-SURGERY-ALB |
| Manufacturer Street | 3801 UNIVERSITY BLVD., SE |
| Manufacturer City | ALBUQUERQUE NM 87125620 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 87125 6202 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROXIMATE I L S INTRALUMINAL STAPLER |
| Generic Name | CIRCULAR STAPLERS |
| Product Code | FHM |
| Date Received | 2000-03-01 |
| Model Number | MA |
| Catalog Number | CDH29 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 258600 |
| Manufacturer | ETHICON ENDO-SURGERY - ALB |
| Manufacturer Address | 3801 UNIVERSITY BLVD., SE ALBUQUERQUE NM 871256202 US |
| Baseline Brand Name | PROXIMATE PROXIMATE PLUS MD SKIN STAPLER |
| Baseline Generic Name | SKIN STAPLERS |
| Baseline Model No | MA |
| Baseline Catalog No | PMW35 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-03-01 |