MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-10-28 for 7832 manufactured by Covidian.
[58670219]
Submit date: 10/28/2016. An investigation is currently underway; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[58670220]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a gauze. The customer reports: surgeon was draining an abscess in a site near the pacemaker, he packed it with iodoform strips and included the cotton ball that is attached to the start of the strip. Patient returned to follow up appointment because site looked worse and when that doc inspected the site he found the cotton ball and removed it. Patient was readmitted and underwent additional surgery to re-clean site and re-pack with iodoform strips.
Patient Sequence No: 1, Text Type: D, B5
[66788566]
Additional information was received providing item code and lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018120-2016-00156 |
| MDR Report Key | 6064447 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-10-28 |
| Date of Report | 2016-10-17 |
| Date Mfgr Received | 2016-10-17 |
| Date Added to Maude | 2016-10-28 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1430 MARVIN GRIFFIN ROAD |
| Manufacturer City | AUGUSTA GA 30906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 7832 |
| Generic Name | CURITY IODOFORM STRP 1/2X5YD STRL |
| Product Code | EFQ |
| Date Received | 2016-10-28 |
| Model Number | 7832 |
| Catalog Number | 7832 |
| Lot Number | 16H084862 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIAN |
| Manufacturer Address | 1430 MARVIN GRIFFIN ROAD AUGUSTA GA 30906 US 30906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-28 |