MAUDE Adverse Event Report: HOLOGIC INC. CYTOLYT SOLUTION; PRESERVATIVE

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2013

Event Type  Injury  

Event Description

A customer in (b)(6) reported a (b)(6) pt (male) swallowed cytolyt solution while at the hosp (b)(6).When the accident happened, the pt was transferred ot the antivenin unit directed by the (b)(6).The pt was monitored and treated by (b)(6) from the (b)(6) of the hosp.Once they received the exact composition of the cytolyt and by comparing the reported % of methanol with the toxicological date, the antivenin unit closed the incident and discharged the pt from the unit.(b)(6) (eu): per the content of the current revision of the (b)(6) guidelines on a medical device vigilance system, this won't be classified as a reportable event.The rationale is as follows: there is no report of vial or cap mfg issues.Our labelling is in line with the current eu guidelines and we list appropriate warnings in our ifu regarding use of the product.This appears to be a case of clinical negligence and the onus is on the user to report via their clinical governance procedures.This would be regarded as a case of abnormal use of the product.The current (b)(6) guidelines also state: 5.1.5.3 consideration for handling abnormal use abnormal use needs not be reported by the mfr to the national competent authority under the reporting procedures.Abnormal use should be handled by the health care facility and appropriate regulatory authorities under specific appropriate schemes not covered by this document.If mfrs become aware of instances of abnormal use, they may bring this to the attention of other appropriate organizations and healthcare facility personnel.

• Brand Name: CYTOLYT SOLUTION
• Type of Device: PRESERVATIVE
• Manufacturer (Section D): HOLOGIC INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: eva maxwell ; 2 navigator rd; londonderry, NH 03053 ; 5082638922
• MDR Report Key: 4101636
• MDR Text Key: 4702573
• Report Number: 1222780-2014-00144
• Device Sequence Number: 1
• Product Code: IFB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2014
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 88 YR