MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-12-14 for IV PREP WIPES 59421200 manufactured by Smith & Nephew Wound Management.
[2504286]
Customer, end-user (b)(6) died from sepsis, abdominal abscess and abdominal wound infection. Ms. (b)(6) was using smith & nephew wipes in the area where she received surgery and the same area was the site of persistent infections.
Patient Sequence No: 1, Text Type: D, B5
[9572439]
Smith & nephew was contacted regarding the above described incident, which was reported as a field complaint for adverse incident. The customer did not return any product and no lot number was provided. The complaint could not be confirmed. Since no lot number was provided, the manufacturing location of the product could not be determined; hence laboratory testing or the results were not available for review. The control samples for all lots of iv prep wipes recalled by s&n were tested and it met all product specifications with no evidence of microbial growth found. The production records were not reviewed for this investigation. We were unable to determine a specific root cause for this issue. However, independent medical review of similar complaints with this product concluded there was no correlation with the use of iv prep wipes. Sometimes skin irritation and local infection is expected to occur at normal use and the severity is non-serious injury and some discomfort. It is critical that the solvent is completely dried out before the site is used to prepare for injection. Iv prep is an otc drug and is an anti-septic for iv site preparation. At this time no further actions can be taken on this complaint - (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2011-00058 |
| MDR Report Key | 2374400 |
| Report Source | 00 |
| Date Received | 2011-12-14 |
| Date of Report | 2011-11-30 |
| Date of Event | 2011-10-25 |
| Date Mfgr Received | 2011-10-24 |
| Date Added to Maude | 2011-12-15 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR TERRY MCMAHON |
| Manufacturer Street | 970 LAKE CARILLON DRIVE SUITE 110 |
| Manufacturer City | ST. PETERSBURG FL 33716 |
| Manufacturer Country | US |
| Manufacturer Postal | 33716 |
| Manufacturer Phone | 7273993785 |
| Manufacturer G1 | SMITH & NEPHEW WOUND MANAGEMENT |
| Manufacturer Street | 970 LAKE CARILLON DRIVE SUITE 110 |
| Manufacturer City | ST. PETERSBURG FL 33716 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33716 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IV PREP WIPES |
| Generic Name | BANDAGE, LIQUID, SKIN PROTECTANT |
| Product Code | NEC |
| Date Received | 2011-12-14 |
| Model Number | 59421200 |
| Lot Number | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW WOUND MANAGEMENT |
| Manufacturer Address | 970 LAKE CARILLON DRIVE SUITE 110 ST. PETERSBURG FL 33716 US 33716 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-12-14 |