MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-08-18 for IV PREP WIPES 59421200 manufactured by Smith & Nephew Wound Management.
[16104510]
This iv prep complaint was received post smith & nephew's remedial action (voluntary recall) to prevent an unreasonable risk of substantial harm to the public health (ref. Recall #3006760724-030211-001r). Patient's kidney shut down, and she was admitted as inpatient on (b)(6), 2011. Emergency physician prescribed an antibiotic to which the patient experienced an allergic reaction. Patient also noticed redness on her side, and states she had a reaction to skin prep wipes which caused bronchitis.
Patient Sequence No: 1, Text Type: D, B5
[16242096]
Active investigation in progress; investigation results to be provided in a supplement report. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[18017926]
The customer sent in some product samples. We were unable to confirm the complaint based on inspection of the returned samples, hence laboratory testing was performed. Both the returned sample(s) and control samples (from stock) of lot 0k193 were analyzed by an independent test laboratory and met finished product specifications with no evidence of microbial contamination found. Batch records for the lot indicate all specifications were met at the time of release and no inconsistencies were noted. An independent medical review concluded there was no correlation between the reported symptoms and the use of iv prep wipes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2011-00018 |
| MDR Report Key | 2216606 |
| Report Source | 04 |
| Date Received | 2011-08-18 |
| Date of Report | 2011-12-12 |
| Date of Event | 2011-07-27 |
| Date Mfgr Received | 2011-07-27 |
| Date Added to Maude | 2011-08-22 |
| 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 | 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 | 2011-08-18 |
| Model Number | 59421200 |
| Catalog Number | 59421200 |
| Lot Number | 0K193 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization | 2011-08-18 |