MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06,07 report with the FDA on 2014-10-17 for PROTOCOL ADMIN SET NI manufactured by Ezem.
[5037115]
Case received from a ct clinical specialist at (b)(6) on (b)(6) 2014 and forwarded to (b)(4)) on the same day. Additional info was obtained from the reporter directly at (b)(4) on (b)(4) 2014. A health professional reports: an (b)(6)-year-old female pt had undergone a colonoscopy on (b)(6) 2014 and the procedure could not be completed beyond 60 cm. Therefore, a ct colonography was performed with protoco2l administration set insufflator (lot number 50704075, serial number (b)(4)) on (b)(6) 2014. While the pt was supine on the table and co2 gas ran out the cylinder was changed and they proceeded with the examination. The pt well tolerated the examination, she did not have any pain and was asymptomatic. On the ct, the radiologist suspected a perforation with free air, however, the location could not be identified. The ct colonography also revealed extensive diverticular disease and looping of the colon which was considered the cause, why the colonoscopy had not been successful. The pt subsequently was admitted to the surgical unit for 6-7 days. The reporter did not consider there was a connection between the non-completed colonoscopy on (b)(6) 2014 and the suspected perforation. The reporter assessed the asymptomatic bowel perforation as related to the underlying diverticular disease. The insufflator was not used after this pt. Outcome: unk. Further info has been requested. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12391640]
Company comments: an (b)(6)-year-old female pt with extensive diverticular disease underwent a colonoscopy for an unk indication. The procedure could not be completed due to both pt's underlying disease and formation of loops in colon during the procedure. Therefore, 12 days after the pt underwent a ct colonoscopy with protoco2l. During the ct following co2 insufflation, free air outside of the colon was seen leading to the diagnosis of suspected bowel perforation. No info on total amount of gas, maximum pressure used during the procedure and duration on the procedure is available. As the pt had no clinical symptoms neither during the examination nor subsequently to this investigation, the clinical picture is unlikely for a serious bowel perforation he event was assessed as pt related by the reporter. Bracco agrees that the extensive diverticular disease in this elderly pt could have favored this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2411512-2014-00009 |
| MDR Report Key | 4202121 |
| Report Source | 00,01,05,06,07 |
| Date Received | 2014-10-17 |
| Date of Report | 2014-09-18 |
| Date of Event | 2014-09-18 |
| Date Mfgr Received | 2014-09-18 |
| Date Added to Maude | 2014-10-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 259 PROSPECT PLAINS RD BLDG H |
| Manufacturer City | MONRO TWP NJ 08831 |
| Manufacturer Country | US |
| Manufacturer Postal | 08831 |
| Manufacturer Phone | 8002575181 |
| Manufacturer G1 | EZEM |
| Manufacturer Street | 532 BROADHOLLOW RD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11747 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTOCOL ADMIN SET |
| Generic Name | PROTOCOL COLON INSUFFLATOR - 6400 |
| Product Code | FCX |
| Date Received | 2014-10-17 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | 50704075 |
| ID Number | NA |
| Operator | OTHER |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EZEM |
| Manufacturer Address | 532 BROADHOLLOW RD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-10-17 |