MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-10-20 for IV PREP WIPES 59421200 manufactured by Smith & Nephew Wound Management.
[2248440]
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). Initial report received from cder surveillance programs team, ref msb file no: (b)(4). On or around (b)(6) 2011, patient was having symptoms of fever, flu-like symptoms, weakness and body aches which caused her to go to the er and then was hospitalized. Tested negative for flu virus and was given iv antibiotic.
Patient Sequence No: 1, Text Type: D, B5
[9314508]
Smith & nephew was contacted regarding the above described incident, which was reported as a field complaint for "infection-general / systemic". There was no product returned by the customer. Control samples (from retain stock) of the reported lots 0k139 were analyzed by an independent test laboratory and met finished product specifications with no evidence of microbial contamination found in the control samples. The product was manufactured and released after all specifications were met. This lot was manufactured and released in october 2010 and no complaints were reported until (b)(4) 2011. An independent medical review of the complaint confirmed iv prep wipes cannot be linked to the reported symptoms. Further investigation or corrective action cannot be taken at this time. Any future complaints related to this product will be tracked and trended, and should a significant trend of this issue occur, corrective action will take place at that time. We were unable to determine a specific root cause for the reported issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2011-00053 |
| MDR Report Key | 2302415 |
| Report Source | 00 |
| Date Received | 2011-10-20 |
| Date of Report | 2011-10-17 |
| Date of Event | 2011-06-28 |
| Date Facility Aware | 2011-06-28 |
| Date Mfgr Received | 2011-06-28 |
| Date Added to Maude | 2011-10-20 |
| 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 | 0 |
| 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 |
| Removal Correction Number | 3006760724-030211-001R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IV PREP WIPES |
| Generic Name | BANDAGE, LIQUID, SKIN PROTECTANT |
| Product Code | NEC |
| Date Received | 2011-10-20 |
| Catalog Number | 59421200 |
| Lot Number | 0K139 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW WOUND MANAGEMENT |
| Manufacturer Address | 970 LAKE CARILLON DRIVE SUITE 110 ST. PETERSBURG FL 33176 US 33176 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-10-20 |