MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-10-20 for IV PREP WIPES 59421200 manufactured by Smith & Nephew Wound Management.
[2251685]
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). Adverse incident ms. (b)(6) was hospitalized due to a bacterial infection during the time she was using antiseptic wipes, iv prep.
Patient Sequence No: 1, Text Type: D, B5
[9312186]
Smith & nephew was contacted regarding the above described incident, which was reported as a field complaint for "infection-general/systemic". No product was returned by the customer and no lot number was provided. Control samples (from stock) of all lots of iv prep wipes produced at this manufacturing facility were analyzed by an independent test laboratory and met finished product specifications with no evidence of microbial contamination found. Batch records for the lots indicate all specifications were met at the time of release and no inconsistencies were noted. We were unable to determine a specific root cause for this issue. An independent medical review concluded there was insufficient evidence to support a relationship between the reported symptoms and the use of iv prep wipes. See attached investigation results for additional details.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2011-00050 |
| MDR Report Key | 2301995 |
| Report Source | 04 |
| Date Received | 2011-10-20 |
| Date of Report | 2011-06-17 |
| Date of Event | 2011-06-17 |
| Date Mfgr Received | 2011-06-17 |
| 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 |
| Model Number | 59421200 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| 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 33176 US 33176 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-10-20 |