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 2017-10-31 for MEMOBAG EXTRACTION BAG 200ML NA VERSION 332802-000010 manufactured by Teleflex Medical.
[91199424]
(b)(4). The facility has communicated that the device is not available for evaluation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[91199425]
Issue reported: the physician was performing a laparoscopic appendectomy on a patient. The bag was removed through a 15 mm fascial hole. A smaller appendix was being removed. No instrumentation on the bag was done. The bag ripped when pulling the specimen out of the defect and the specimen fell through the bag when the bag was pulled through the fascia. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2017-00494 |
| MDR Report Key | 6990563 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-31 |
| Date of Report | 2017-10-16 |
| Date of Event | 2017-10-13 |
| Date Mfgr Received | 2017-12-05 |
| Date Added to Maude | 2017-10-31 |
| 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 | 3 |
| Brand Name | MEMOBAG EXTRACTION BAG 200ML NA VERSION |
| Generic Name | BAG, INTESTINE |
| Product Code | KGY |
| Date Received | 2017-10-31 |
| Returned To Mfg | 2017-11-14 |
| Catalog Number | 332802-000010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-10-31 |