MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-19 for KENDALL CURITY IODOFORM STRIPS 7831 manufactured by Tyco Healthcare Group Lp.
[78050386]
Got staph infection / (b)(6) from c-section on (b)(6) 2012. Use of "kendall curity iodoform packing material strip" was used out of date. Product expired on january 2008 and second bottle of same product used on me expired on june 2009. (for staph and (b)(6). ) dr. (b)(6) - (b)(6). Dates of use: "from (b)(6) 2012. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070510 |
| MDR Report Key | 6653100 |
| Date Received | 2017-06-19 |
| Date Added to Maude | 2017-06-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KENDALL CURITY IODOFORM STRIPS |
| Generic Name | PACKING MATERIAL |
| Product Code | EFQ |
| Date Received | 2017-06-19 |
| Model Number | 7831 |
| Device Expiration Date | 2008-01-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TYCO HEALTHCARE GROUP LP |
| Manufacturer Address | MANSFIELD MA 02048 US 02048 |
| Brand Name | KENDALL CURITY IODOFORM STRIPS |
| Generic Name | PACKING MATERIAL |
| Product Code | EFQ |
| Date Received | 2017-06-19 |
| Device Expiration Date | 2009-06-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | TYCO HEALTHCARE GROUP LP |
| Manufacturer Address | MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-19 |