MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-13 for EXTRACTION BAG FOR MIS 332801-000020 manufactured by Teleflex Medical.
[145106577]
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[145106578]
It was reported that during an appendectomy under laparoscopy, the bag ruptured in intra-peritoneal resulting in dissemination. Another bag needed to be used. Additional information states that the patient had a longer stay in the hospital and antibiotic therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2019-00362 |
| MDR Report Key | 8603813 |
| Date Received | 2019-05-13 |
| Date of Report | 2019-05-09 |
| Date of Event | 2019-04-27 |
| Date Mfgr Received | 2019-06-20 |
| Device Manufacturer Date | 2019-03-04 |
| Date Added to Maude | 2019-05-13 |
| 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 | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | ARROW INTERNATIONAL CR, A.S. |
| Manufacturer Street | JAMSKA 2359/47 |
| Manufacturer City | ZDAR NAD SAZAVOU 591 01 |
| Manufacturer Country | EZ |
| Manufacturer Postal Code | 591 01 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EXTRACTION BAG FOR MIS |
| Product Code | KGY |
| Date Received | 2019-05-13 |
| Catalog Number | 332801-000020 |
| Lot Number | 71F19B2089 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | ATHLONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-13 |